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Author Topic: Deep brain stimulator - Seizures  (Read 54047 times)
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dennis100
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« on: November 06, 2013, 01:43:06 AM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 11/02/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: romito lm, contarino fm, albanese a. Transient gender-related effects in parkinson's disease pts with subthalamic stimulation. J neurol. Apr 2010;257(4):603-608. Summary: this study assessed the possible gender differences in clinical outcome and disease progression along a 5-year period after subthalamic nucleus deep brain stimulation (stn-dbs) for parkinson's disease. Clinical outcome, disease progression and adverse events were assessed at baseline and 1, 3, and 5 years after surgery. The first 20 consecutive pd pts who received bilateral implant for stn stimulation and reached the 5-year period were f/u (11 men, 9 women) were included in the study. Dopamine agonists were withdrawn one week before surgery and levodopa the evening before. Medication was gradually introduced after implant just to the dose necessary to permit optimal motor control in addition to stimulation. Each post-operative test session used three unified parkinson's disease rating scale evaluations and looked at medication off/stimulation off, medication off/stimulation on, and medication on/stimulation on conditions. Adverse events were classified as transient, persistent (if not improved by turning off stimulation for a short time), stimulation-induced (present at optimal stimulation parameters, but improved when stimulation was turned off or parameters were modified), device-related, or unrelated to the procedure or stimulation. Reportable events: one male pt experienced unexplained switching off of the dbs. One female pt experienced unexplained switching off of the dbs. One male pt experienced cable dehiscence due to infection. One male pt experienced transient seizures responsive to antiepileptic drugs.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time no additional info was available, additional info regarding the pt, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107262

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dennis100
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« Reply #1 on: November 06, 2013, 01:45:39 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.
 
Event Description

Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229

« Last Edit: February 04, 2014, 03:02:28 AM by dennis100 » Logged
dennis100
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« Reply #2 on: November 06, 2013, 01:46:35 AM »

Model Number IPGNEURO
Device Problems Malposition of device; Battery issue
Event Date 04/30/2010
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

(b)(4) suicide -(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with the previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: kishore a, rao r, krishnan s, et al. Long-term stability of effects of subthalamic stimulation in parkinson's disease: indian experience. Mov disord. Oct 30 2010; 25(14):2438-2444. Summary: the authors reported on 45 consecutive pts who received bilateral subthalamic nucleus (stn) stimulation for parkinson disease (pd) from 1999 to 2004. Of the 45 pts, 18 were women and 27 men; their average age was 44. 1 years. Pts showed a stable and substantial reduction in the cardinal signs of pd, motor fluctuations, and dyskinesias, but less so for axial signs. The reduction in medications and the intensity of electrical stimulation needed also remained stable during follow up. This is the first report of stn stimulation in asian pts with pd. Reportable events: the authors indicated that there were several complications of subthalamic stimulation: they are summarized below: two pts experienced intra operative seizures; both were small pneumocephalus; one pt experienced fluid collection at the battery implantation site necessitating reimplantation; two pts experienced hardware failure of the battery (unspecified); two pts experienced led repositioning; one pt experienced a fall and lead breakage; one pt experienced new-onset of severe depression; eight pts experienced new-onset of apathy; one pt committed suicide at 4 years. The source literature did not specify which device models were used.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909862
« Last Edit: February 04, 2014, 03:02:45 AM by dennis100 » Logged
dennis100
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« Reply #3 on: November 06, 2013, 01:47:52 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 10/15/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b)(4). Subdural air (no bleeding). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: bour lj, contarino mf. Foncke em, et al. Long-term experience with intraoperative microrecording during dbs neurosurgery in stn and gpi. Acta neurochir (wien). Dec 2010;152(12):2069-2077. Summary: intraoperative microelectrode recording (mer) for targeting during deep brain stimulation (dbs) procedures was evaluated by the authors over a period of 4 years, in 57 consecutive pts with parkinson's disease, who received dbs in the subthalamic nucleus (stn-dbs), and 28 consecutive pts with either dystonia (23) or parkinson's disease (five), in whom the internal segment of the globus pallidus (gpi-dbs) was targeted. The results indicate that mer facilitates the selection of the final electrode location in stn-dbs and gpi-dbs, and based on the observed mer activity, a pre-selection could be made as to which channel would be the best candidate for micro-test stimulation and at which depth should be stimulated. The choice of the final location is based on intraoperative test stimulation, and it is demonstrated that regularly it is not the central channel that is chosen for implantation. On average, the target as defined by mer activity intensity was in accordance with the mri-based targets both for the stn and gpi. However, the position of the best mer activity did not necessarily correlate with the locus that produced the most beneficial clinical response on macroelectrode testing intraoperatively. Reportable event: one pt undergoing stn-dbs had a generalized seizure on postoperative day 1. Ct showed bilateral subdural air, but no bleeding. See literature article with mfr report #3007566237201010775.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1946755
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dennis100
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« Reply #4 on: November 06, 2013, 01:48:17 AM »

Device Problem No Information
Event Date 12/07/2010
Event Type  Injury   Patient Outcome  Other
Event Description

It was reported about two months after implant the patient had two epileptic seizures. The first seizure occurred at the first programming session, and the other seizure occurred two weeks later under constant stimulation. The patient had no known history of epilepsy. The patient was given anti-epileptic medication and recovered without sequela. So far there have been no other seizures. It was noted that during the implant, the wrong extensions were implanted "due to an error in the operating room. " the intent was to use dbs approved extensions with the model numbers 7482 and 7482a.
 
Manufacturer Narrative

(b)(4). This report is being submitted late due to a delay by a manufacturer employee. A process improvement plan and training are in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000253
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dennis100
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« Reply #5 on: November 06, 2013, 01:48:41 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/06/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4): pneumocephalus), (hypodense area). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events.
 
Event Description

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient, symptomatic, post-operative, non-infectious hypo density around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011; 18(7):910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) female presented to the emergency room with seizures 30 days following stn dbs implantation. Edema was found along the whole lead. The pt was given steroids and anti-epileptic medication for 42 days for this to resolve. See literature article with mfr report # 3007566237201107706.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250681
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dennis100
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« Reply #6 on: November 06, 2013, 01:49:05 AM »

Model Number NEU_UNKNOWN
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported since internal neurostimulator (ins) replacement surgery in (b)(6), 2011 the patient started having gran-mal seizures with cyanosis at the same time on fridays. The patient was put on anticonvulsants to no avail. Patient outcome is unknown. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2622311

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dennis100
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« Reply #7 on: November 06, 2013, 01:49:33 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/22/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: foltynie t, zrinzo l, martinez-torres i, et at. Mri-guided stn dbs in parkinson's disease without microelectrode recording: efficacy and safety. J neurol neurosurg psychiatry. Apr 2011; 82(4): 358-363. Summary: this series describes the outcomes of 79 consecutive pts that underwent bilateral stn dbs at the national hosp for neurology and neurosurgery between (b)(6) 2002 and (b)(6) 2008 using an mri-guided surgical technique without microelectrode recording. Pts showed significant improvements in dyskinesia duration, disability and pain, with a mean reduction in on-medication dyskinesia severity from 3. 15 pre-operatively to 1. 56 post-operatively. Quality of life improved by a mean of 5. 5 points on the parkinsons disease index. This series confirms that image-guided stn dbs without microelectrode recording can lead to substantial improvements in motor disability of well selected pd pts with accompanying improvements in quality of life and with very low morbidity. Reportable event: the authors report that one pt had an unplanned staged bilateral procedure because of a complex partial seizure that followed the insertion of the first electrode. See literature article attached to mfr report # 3007566237-2011-07448.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246568
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dennis100
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« Reply #8 on: November 06, 2013, 01:49:58 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/06/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4) (pneumocephalus; hypodense area). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events.
 
Event Description

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011:18(7);910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) left-handed male with a history of idiopathic parkinson's disease (pd) was admitted for placement of a right-sided stn electrode. Immediate post-operative ct head scans revealed minimal pneumocephalus with no parenchymal hemorrhage. The pt was discharged on postoperative day 2 with a normal exam. His second stage of surgery for implantation of the ipg was scheduled for a later date. Two weeks after discharge, the pt presented to the emergency room with a history of a single generalized convulsion followed by a brief loss of consciousness. On exam he was orientated and had no focal deficits. A ct brain scan revealed a large hypodense area (3cmx4cmx3cm) centered around the left dbs electrode primarily in the subcortical region and centrum semiovale that did not enhance on contrast administration. No local or systemic signs or symptoms of infection were present. He did not have any further episodes of seizure and was discharged home on anti-convulsant medication and a short course of oral steroids. A f/u ct scan after 1 week showed resolution of the edema. The pt was not given antibiotics. See literature article with mfr report # 3007566237201107706.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250706
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« Reply #9 on: November 06, 2013, 01:50:20 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/20/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: johnson rd, qadri sr, joint c, moir l, green al, aziz tz. Perioperative seizures following deep brain stimulation in patients with multiple sclerosis. Br j neurosurg. Jun 2010;24(3):289-290. Summary: this article discussed the occurrence of seizures during the peri-operative period in two thalamic deep brain stimulation (dbs) patients with histories of tremor and multiple sclerosis (ms). Event: a (b)(6) female patient with a history of intention tremor of the hands, ms and a right thalamotomy, experienced erosion of the lead through the skin four years after left thalamic dbs implantation that provided relief of the right sided tremor. The lead was removed. A repeat left thalamic dbs was inserted five years after the first implant, after which the patient experienced a one-minute grand mal seizure 24 hours post-operatively. The patient was post-ictal for several minutes, was given phenytoin, and recovered well within 20 minutes with no further neurological deficits. A ct head scan ruled out hematomas. Phenytoin was discontinued and the patient did not suffer any more seizures. See mfr. Report #3007566237-2011-03976 regarding the other patient mentioned in the article.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115045

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dennis100
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« Reply #10 on: November 06, 2013, 01:50:44 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/29/2010
Event Type  Death   Patient Outcome  Death
Event Description

Literature: williams a, gill s, varma t, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced parkinson's disease (pd surg trial): a randomised, open-label trial. Lancet neurol jun 2010;9(6):581-591. Summary: this article discussed the results of a one-year f/u in an ongoing, randomized, open-label trial involving 13 centers in (b)(6) of 366 patients with parkinson's disease (pd) that was not controlled by medical therapy who were randomly assigned between (b)(6) 2000 and (b)(6) 2006 to immediate surgery (deep brain stimulation) and best medical therapy or best medical therapy alone. The subthalamic nucleus was the target in 174 out of 178 surgery patients, and 176 of the 178 procedures were bilateral. Patients in both groups received medical therapy, which could have included apomorphine, other dopamine agonists, monoamine oxidase type b inhibitors, cathechol-o-methyltransferase inhibitors, amanatadine, or other drugs used for pd. The primary data used was pt self-reported quality of life on the 39-item pd questionaire. Clinical assessments of functioning using the unified parkinson's disease rating scale in both on and off states and cognitive states using the dementia rating scale-ii also were performed. Changes between baseline and one year were compared. Serious and non-serious adverse events were also recorded. Serious adverse events were defined as those events that resulted in a prolonged stay in the hospital, hospital admission, were thought to be life-threatening, or resulted in death. Reportable event: all of the following events were designated "serious adverse events" as defined above: one pt died from hemorrhage during implantation surgery. Two patients experienced surgery-related hemorrhage. One pt had a hemorrhage five months after surgery. The hemorrhage was considered "probably not" treatment related. Sixteen pts developed surgery related infections. Five patients experienced post-operative confusion that was considered dbs-specific. Two patients experienced neck pain that was considered surgery related dbs-specific. Two patients experienced seizures that were considered surgery related, dbs-specific. One pt experienced deteriorating control of pd because the battery was switched off. There was no allegation that the device malfunctioned. One pt experienced psychosis that was considered surgery related, dbs-specific. One pt became unresponsive on the operating table. The authors believed this possibly to be related to levodopa withdrawal. One pt experienced visual neglect from edema that was considered surgery related, dbs-specific. Four patients experienced urinary retention that was considered general surgery related. Two patients experienced pulmonary embolism that was considered general surgery related. One pt experienced an anxiety attack that was considered general surgery related. One pt experienced post-operative hypotension. In one pt, there was difficulty removing the catheter after surgery. One pt experienced pyrexia that was considered general surgery related. Three patients experienced falls that were considered pd related and/or drug related. Two patients experienced constipation that was considered pd related and/or drug related. One pt experienced two episodes of constipation that was considered pd related and/or drug related. Eleven patients experienced worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related. One pt experienced two episodes of worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested. Two patients experienced chest pain that was not categorized as surgery related or pd related or drug related. One pt experienced angina that was not categorized as surgery related or pd related or drug related. Three patients experienced pain that was not categorized as surgery related or pd related or drug related. Three patients experienced neuropsychiatric disturbance (including hallucinations or paranoia) that were considered pd related and/or drug related. One pt attempted suicide that was considered pd related and/or drug related. The pt previously had attempted suicide prior to trial entry. Two patients had unspecified pd drug related adverse events. Two patients experienced chest infections that were not categorized as surgery related or pd related or drug related. One pt collapsed, which was not categorized as surgery related or pd related or drug related. One pt experienced deep vein thrombosis more than 8 months after surgery that was not categorized as surgery related to pd related or drug related. One patient experienced pulmonary embolism more than 8 months after surgery that was not categorized as surgery related, pd related or drug related. One pt experienced a fainting episode that was not categorized as surgery related or pd related or drug related. One pt experienced vertigo that was not categorized as surgery related or pd related or drug related. Five patients experienced urinary problems that were not categorized as surgery related or pd or drug related.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116650
« Last Edit: February 04, 2014, 03:03:10 AM by dennis100 » Logged
dennis100
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« Reply #11 on: November 06, 2013, 07:32:33 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Life Threatening
Manufacturer Narrative

(b) (4).
 
Event Description

Literature: susatia f, malaty ia, foote kd, et al. An evaluation of rating scales utilized for deep brain stimulation for dystonia. J neurol. Jan;257(1): 44-58. Summary: the objective of this study was to examine globus pallidus internus deep brain stimulation (gpi-dbs) outcomes in primary and secondary dystonia, derived from blinded ratings using two scales and two raters. Of thirty two patients who underwent dbs surgery at the movement disorder center at (b) (6), twenty five patients met the inclusion criteria and completed the video tape recording within one year post surgery. Event: there were two events of seizure. No further information was provided. See literature article with mfr report #3007566237-2010-03026.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1660262

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« Reply #12 on: November 06, 2013, 07:32:51 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/12/2010
Event Type  Injury   Patient Outcome  Life Threatening
Manufacturer Narrative

(b) (4).
 
Event Description

Literature: ferraye mu, debu b, fraix v, et al. Effects of pedunculopontine nucleus area stimulation on gait disorders in parkinson's disease. Brain. Jan;133(pt 1):205-214. Summary: the study looked at the effects of stimulating the pedunculopontine nucleus (ppn) area in six pts with severe freezing of gait due to parkinson's disease (pd). The pts had been unresponsive to levodopa and subthalamic nucleus (stn) stimulation. Event: one pt displayed two epileptic seizures 1 week after electrode implantation. The pt fully recovered. See literature article with mfr report# 3007566237-2010-02940.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658297

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« Reply #13 on: November 06, 2013, 11:44:53 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: greenberg bd, gabriels la, malone da jr, rezai ar, friehs gm, okun ms, shapira na, foote kd, cosyns pr, kubu cs, malloy pf, salloway sp, giftakis je, rise mt, machado ag, baker kb, stypulkowski ph, goodman wk, rasmussen sa and nuttin bj. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Molecular psychiatry. 2008: 1-16. Summary: this article represents combined long-term (8 yrs; from 1998) results from the united states and europe of deep brain stimulation (dbs) of the ventral anterior limb of the internal capsule and adjacent ventral striatum (vc/vs) for severe and highly treatment-resistant obsessive-compulsive disorder. A total of 26 patients reveal clinically significant symptom reductions and functional improvement in about two-thirds of patients. Dbs was well tolerated overall and adverse effects were overwhelmingly transient. Results generally improved for patients implanted more recently, suggesting a 'learning curve' both within and across centers. None of the 26 patients were rated as globally 'worse' or 'slightly worse' after stimulation; 4 (15. 4%) were rated 'unchanged'; 5 (19. 2%) were rated 'slightly better' and 17 (65. 4%) were rated 'much better'. Event: one patient had a single generalized tonic-clonic seizure after lead implantation in the operating room, which prompted prophylactic phenytoin treatment after surgery, which was discontinued after 1 month, without seizure recurrence. Refer to manufacturer report number: 3007566237-2009-08664.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1548576


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« Reply #14 on: November 06, 2013, 11:46:03 AM »

Device Problem No Known Device Problem
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: bauman ja, church e, halpern ch, et al. Subcutaneous heparin for prophylaxis of venous thromboembolism in deep brain stimulation surgery: evidence from a decision analysis. Neurosurgery. 2009;65(2):276-280. Summary: this article presents a retrospective review of 254 patients with movement disorders who underwent deep brain stimulation (dbs) surgery between 2003 and 2007 to investigate the safety of subcutaneous heparin (sqh) in patients undergoing dbs surgery. The patient's were divided into two groups, non-sqh implanted prior to some time in 2005 and sqh implanted after that time in 2005. Reportable event: five sqh patients developed an asymptomatic intracranial hemorrhage diagnosed via postoperative mri. The hemorrhages were noted to be small bilateral subdural hematomas in two patients and small unilateral hematomas adjacent to the dbs lead in the other three patients. One patient with a hematoma experienced a generalized tonic-clonic seizure. The relationship between the seizure and the intracranial hemorrhage were unknown. It was not specified whether the patient who had the seizure had a bilateral or unilateral hemorrhage. There were no other symptoms. None of the patients required surgical intervention. See literature article with mfr report #3007566237-2009-09427.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566215
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« Reply #15 on: November 09, 2013, 02:21:27 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

 
Event Description

Journal reference: paek sh, han jh, lee jy, kim c, jeon bs, kim dg, electrode position determined by fused images of preoperative and subthalamic nucleus deep brain stimulation. Neurosurgery. 2008;63(5):925-937. The electrode position is important to the surgical outcome after subthalamic nucleus (stn) deep brain stimulation (dbs). The aim of this study was to compare the surgical outcome of parkinson's patients of bilateral stn dbs with the electrode position estimated using fused magnetic resonance imaging. Reportable event: seizures developed in 2 patients but were well controlled with antiepileptic drugs. See mfg report #2182207-2008-08567.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273862
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« Reply #16 on: November 09, 2013, 12:05:06 PM »

Device Problem No Known Device Problem
Event Date 09/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: coley e, farhadi r, lewis s, whittle ir. The incidence of seizures following deep brain stimulating electrode implantation for movement disorders, pain and psychiatric conditions. Br j neurosurg. 2009; 23(2): 179-183. Summary: this article presents a literature review of 32 papers found using a search strategy trawling through papers describing clinical case series of dbs that described stereotactic placement of dbs electrodes for movement disorders, pain syndrome, and psychiatric conditions with cohorts of n>5. The aim of the study was to provide estimates of the procedural related seizures or epilepsy following chronic dbs for movement disorders, pain, and psychiatric conditions. Reportable event: one pt experienced delayed chronic seizure disorder following bilateral gpi dbs implantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511288
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« Reply #17 on: November 10, 2013, 03:54:29 AM »

Device Problem Device remains implanted
Event Date 05/31/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: romito lm, contarino mf, vanacore n, bentivoglio ar, scerrati m, albanese a. Replacement of dopaminergic medication with subthalamic nucleus stimulation in parkinson's disease: long-term observation. Mov disord. 2009; 24(4): 557-563. Summary: the article reports a long-term prospective evaluation of 20 patients diagnosed with parkinson's disease after bilateral subthalamic nucleus (stn) implants. Patients were evaluated preoperatively and then 6, 12, 18 months and 2, 3, 5 years after the implant. Reportable event: one patient experienced a transient seizure that was responsive to antiepileptic drugs. It was not reported how this was related to the stimulation therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1413203

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« Reply #18 on: December 07, 2013, 06:18:46 AM »

Model Number 37601
Event Date 02/26/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The patient had bilateral lead placement on (b)(6) 2013 without postoperative complications. The patient then developed sudden loss of consciousness and then re-awoke with tachycardia. The blood pressure was normal but there was a new seizure onset. A ct scan without contrast was done. The expected surgical pneumocephalus was decreasing. Lab and eeg results were normal on (b)(6) 2013. This event resulted in in-patient hospitalization and was possibly related to the implant procedure. The patient recovered without sequela on (b)(6) 2013.

 
Manufacturer Narrative
Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, va03e59, implanted: (b)(6) 2013, product type: lead, product id: 3387s-40, lot# va03e59, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3458350
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« Reply #19 on: December 07, 2013, 06:19:18 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
Concomitant products: product id: 3389s-40, lot# v798530, implanted: (b)(6) 2011,product type: lead. Product id: 37642, serial# (b)(4),product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

 
Event Description
It was reported that a patient had a seizure and was in the hospital. It was stated that the patient needed a brain/head scan due to the seizure. The cause of the seizure was unknown. Compatibility guidelines were requested for mri and ct/cat scans.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3445363
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« Reply #20 on: December 07, 2013, 06:20:36 AM »

Model Number 3389S-40
Event Date 10/31/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that there was unexplained edema surrounding the lead. It was noted that an explant of the lead was planned for (b)(6) 2013. It was noted that the patient had one complete left deep brain stimulation system implanted last year. It was noted that the patient was then implanted with a lead on the right side. It was noted that approximately 1 to 2 weeks later the patient was presented to the er with seizures. It was noted that a ct of the lead noted a non-infectious swelling surrounding the end of the lead. It was noted that the surgeon was convinced that it was not an abscess or infection. It was noted that they were not certain if the issue was the product, procedure or patient related. It was noted that the lead was being removed. It was noted that the patient was hospitalized and the reporter was unsure of what medical intervention was done. It was noted that multiple ct scans were performed. Additional information received reported that the patient did not have seizures but had more symptoms that resembled a stroke.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479050
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« Reply #21 on: December 09, 2013, 05:46:38 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Death   Patient Outcome  Death,Required Intervention,Disability
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. The patient information provided in section a is an average for all the patients. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

 
Event Description
Franzini, a. , cordella, r. , messina, g. , marras, c. E. , romito, l. M. , carella, f. , albanese, a. , rizzi, m. , nardocci, n. , zorzi, g. , zekay, e. , broggi, g. Deep brain stimulation for movement disorders. Considerations on 276 consecutive patients. J neural transm. 2 011;118(10):1497-1510. Doi: 10. 1007/s00702-011-0656-z. Summary: the links between stn dbs and advanced parkinson disease, and between gpi dbs and dystonia are nearly universally accepted by the neurologists and neurosurgeons. Nevertheless, in some conditions,targets such as the ventral thalamus and the zona incerta may be considered to optimize the results and avoid the side effects. Positive and negative aspects of current dbs treatments justify the research of new targets, new stimulation programs and new hardware. Since 1993, at the istituto nazionale neurologico ¿¿carlo besta¿¿ in milan, 580 deep brain electrodes were implanted in 332 patients. 276 patients were affected by movement disorders. The dbs targets included stn, gpi, voa, vop, vim, cm¿pf, czi, ic. The long-term follow-up is reported and related to the chosen target. Dbs gave a new therapeutic option to patients affected by severe movement disorders, and in some cases resolved life-threatening pathological conditions that would otherwise result in the death of the patient, such as in status dystonicus, and post-stroke hemiballism us. Nevertheless, the potential occurrence of severe complications still limit a wider use of dbs. At today, the use of dbs in severe movement disorders is strongly positive even if further investigations and studies are needed to unveil potential new applications, and to refine the selection criteria for the actual indications and targets. The experience of different targets may be useful to guide and tailor the target choice to the individual clinical condition. Reported events: 1. 2 patients had a massive brain hemorrhage with a fatal outcome. 2. 6 patients had permanent neurological deficits due to deep hemorrhage 3. 8 patients had transient neurological deficits due to deep hemorrhage. 4. 7 patients had post-operative seizures. 5. 26 patients had hardware removed due to infection. 6. 6 patients had hardware removed due to infection and had a cerebral abscess at the origin of the stereotactic trajectory. 7. 30 patients had a hardware failure. 8. 20 patients had a late electrode migration. 9. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had a brain hematoma with hemiplegia. 10. 1 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had presented an unexplained fracture of the extracranic portion of the lead. It was noted that the patient underwent a successful lead replacement. 11. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had monolateral removal of their systems due to infection. 12. 17 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had hypophonia. 13. 11 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had dysarthria. 14. 1 pediatric patient suffering from a sever from of secondary dystonia had bilateral implantation ofdeep brain stimulation (dbs) system in the globus pallidus interna (gpi) and was successfully treated for 2 years before the stimulation device on the right side became infected because of skin erosion of the head along the path of the connector. It was noted that a right pallidotomy was performed by the dbs electrode before its subsequent definitive removal. 15. 4 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had migration of the electrode. It was noted that the complication was successfully managed. 16. 2 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had breakage of the electrode. It was noted that the complication was successfully managed. 17. 5 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an infection. It was noted that the complication was successfully managed. 18. 1 patient suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an intracranial hemorrhage. 19. 4 patient suffering from parkinson¿s disease with levodopa induced dyskinesia developed severe akinesia resistant to levodopa therapy after 4 years of chronic stimulation. 20. 3 patients had bilateral thalamic implants and had speech impairment. 21. 3 patients with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and were completely invalid. It was further reported that these patients did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. 22. 1 patient with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and was completely invalid. It was further reported that this patient did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. Additionally it was noted that surgery was followed by a relapse of the demyelinating disease. 23. 19 patients affected by advanced parkinson¿s disease had bilateral implants in the pre-lemniscal radiation (raprl) and had an incident of speech impairment of 36% and depression of 18%. 24. 4 patients affected by advanced parkinson¿s disease had asymmetrical implants in the pre-lemniscal radiation (raprl) and in the causal zona incerta (czi) on the contralateral side and had an incident of speech impairment of 36% and depression of 18%. Please refer to manufactures report # 3007566237-2013-02368 for additional information on a related event. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3233746
« Last Edit: February 04, 2014, 03:03:40 AM by dennis100 » Logged
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« Reply #22 on: December 10, 2013, 04:28:05 AM »

Model Number 37602
Event Type  Death   Patient Outcome  Death,Other
Event Description
It was reported the patient had suffered 2 seizures on monday following a device replacement. The patient could not talk or walk, and a stroke had been ruled out. The patient was at the hospital. Per the reporter, the patient looked like he was having an electrical shock in his upper body and it brought him to the ground. The reporter had seen the patient "shudder" during programming sessions in the past, and the reporter was concerned the device was related to the problem. The patient's health care professional did not think the devices were working, but this was not confirmed and the devices had not been turned off. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 
Manufacturer Narrative
Product id 748251, serial # (b)(4), implanted: (b)(6) 2006; product type extension, product id 748251, serial # (b)(4), implanted: (b)(6) 2006; product type extension, product id 37642, serial # (b)(4), product type programmer, product id 3387s-40, lot # v009321, implanted: (b)(6) 2006; product type lead, product id 3387-40, lot # v00200,5 implanted: (b)(6) 2006; product type lead.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was fine when he went into the hospital to get the neurostimulators replaced, and he walked out of the hospital fine after the replacement. The patient was completely fine for a week after the replacement, and event went dancing. His speech had been hard to understand before the replacement, and after the replacement it was stronger and the patient stated "he had never felt better". On (b)(6), the patient was walking from the living room to the bathroom to get ready to go to the hospital to get his stitches out, when his wife heard a fall. She found that he had slid down the bathroom door and was sitting on the floor up against the door, experiencing an electrical shock. The patient was completely awake and alert, and experienced another electrical shock. The patient stated that he didn't know what happened, but it felt funny. The patient went to the hospital to get checked out, where he was seen by his neurosurgeon and a manufacturer representative. It was reported that one side of his body was drastically weaker than the other side, and on one side his leg turned in funny. It was reported that on one neurostimulator the settings looked normal, but on the other one the settings looked really high. The reporter wasn't sure which neurostimulator had the high settings, but she thought it was the left, and the settings were lowered. By (b)(6), the patient was in a semi-coma. While in the hospital, he was violent, was like in a "twilight sleep" and would lash out, wasn't talking, was barely eating and couldn't open his eyes. He was given a cat scan that ruled out a stroke, and blood and urine tests came back normal. It was noted that the patient had a urinary tract infection, but it wasn't bad. (b)(6) days later, the patient went to rehab for four to five days, because he was so aggressive and his eyes couldn't open, like they were stuck shut. The patient got worse in rehab, but it was noted that the hcp never shut off the neurostimulators because he believed it would make the patient's shakes really bad. The patient was taken on his levodopa, and he shook a little. (b)(6) weeks later, he was put into the psych ward and put on psych drugs because he was so aggressive in his sleep. The patient fell on floor a couple times and was then weaned off the psych drugs to make sure he wasn't having a reaction. He was then transferred to a hospice with the plan to transfer him to a home health or nursing home setting once he got better, however the patient died in the hospice. The death certificate listed the cause of death as failure to thrive and advanced parkinson's. Refer to mfr. Rep. # 3004209178-2012-03327.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2575695
« Last Edit: February 04, 2014, 03:03:58 AM by dennis100 » Logged
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« Reply #23 on: December 10, 2013, 04:29:26 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 06/08/2011
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
Date of death is unknown, no estimate available so the date of notification was used.

 
Event Description
Literature: toft m, lilleeng b, ramm-pettersen j, et al. Long-term efficacy and mortality in parkinson's disease patients treated with subthalamic stimulation. Mov disord. 2011. (b)(6). Summary: the authors report on the first 144 patients who received subthalamic nucleus deep brain stimulation (stn-dbs) surgery from january 2001 to december 2007 in this retrospective study. Preoperative scores and at least 1 assessment 12 months after surgery were available for 131 patients (mean age of 60. 3 years). Postoperative evaluation was then carried out annually, with the neurostimulator turned on and patients were followed until december 31, 2008, or death. Reportable event: a (b)(6) female who had an epileptic seizure shortly after electrode implantation died within the first six months of causes probably related to the surgical treatment. Clinical follow-up and brain imaging showed no evidence of a cerebral hematoma or infarction. Her parkinsonian symptoms had worsened at a postoperative examination one month after surgery, but her general medical condition was unchanged. She died of an unknown cause in a rehabilitation clinic three months after the implantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2332493
« Last Edit: February 04, 2014, 03:04:13 AM by dennis100 » Logged
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« Reply #24 on: December 10, 2013, 04:30:15 AM »

Model Number 7426
Event Date 04/18/2012
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the heath care professional (hcp) never had seen seizure symptoms with device. It was unknown if the symptoms were related to the device, therapy, or advancement of parkinsons disease as the seizure-like symptoms were observed in the er setting. Hcp did not know cause of seizure-like symptoms or cause of patient death. No intervention was reported.

 
Event Description
Additional information received reported that the patient saw a physician on (b)(6) 2012. At that time, both devices were dead (eol - end of life) and couldn't read them. It had been over a year since the devices were last checked, as the patient had not seen the physician for over one year. On (b)(6) the physician sent a referral to get the patient's batteries replaced, but not sure if this was ever done. At that time, the patient was in a nursing home and doing poorly. The patient's death had not been reported to the physician's office. If additional information is received, a supplemental report will be filed.

 
Manufacturer Narrative
 
Manufacturer Narrative
Product id 748295 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 748251 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 7438 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ programmer, patient product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead. Product id 7426 (b)(4) implanted 2009-(b)(6) explanted: product typ: neurostimulator. (b)(4).

 
Event Description
It was reported that the patient was having seizure activity. The patient was going to the emergency room for a ct scan. They did not bring the programmer to the er. Additional reporting noted seizure-like symptoms. Ct scan came back within normal limits. The patient was "admitted" to er. There was no known accident or incident related to this issue. The patient had not been seen by managing health care professional since 2008. If additional information is received, a follow up report will be sent.

 
Event Description
Additional information was reported that the patient had died. The cause of death was advanced parkinson's disease. The patient had trouble swallowing and eating and it got progressively worse. The patient chose not to have a feeding tube. The patient had a urinary tract infection about a week before he passed. The caller was able to turn off one internal neurostimulator (ins) but not the other ins. In (b)(6), an ins was replaced. About a month before replacement the patient had difficulty swallowing and lost therapeutic effect. The caller did not know when the ins depleted. Device information could not be obtained. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2563223
« Last Edit: February 04, 2014, 03:04:27 AM by dennis100 » Logged
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« Reply #25 on: December 29, 2013, 03:57:20 AM »

Event Date 08/02/2000
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The pt with severe, medically refractory parkinson's disease, underwent implantation of a medtronic deep brain stimulating -dbs- lead into the right subthalamic nucleus -stn- without incident. Experienced an event compatible with a generalized tonic-clonic seizure while at home. Evaluation at a local hosp, including a ct scan of the head, was unrevealing. The pt was loaded with dilantin and transferred to the med ctr. The pt was found to be at neurological baseline. The ct scan was reviewed and found to show no abnormalities. The pt was continued on dilantin, and was discharged home in good condition. Seizures are a known risk of this procedure, and the risk of seizure is included in the consent form. No changes in the protocol or consent form are deemed necessary based on this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=290666
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« Reply #26 on: December 29, 2013, 03:58:40 AM »

Model Number 7426
Event Date 03/13/2001
Event Type  Other   Patient Outcome  Other
Event Description
The pt has a history of parkinson's disease (pd) since 1994. In 2001 placement of pulse generator system into the left subthalamic nucleus was performed that resulted in near complete pd symptoms resolution. Stimulator was turned off in the immediate post-operative period as usually. At 23:30 pt developed a gran mal seizure. On examination, at 00:15 on the next day the pt was drowsy but arousable and oriented. Pt was put on dilantin and discharged the following day in good condition. Currently, the pt is off dilantin for 1,5 months and seizure-free. No relation of this single episode of seizure to the device has been established.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=332634
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« Reply #27 on: January 02, 2014, 02:45:02 AM »

Model Number 3387
Device Problems Device remains implanted; Tears, rips, holes in device, device material
Event Date 11/01/2006
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The representative reported the pt experienced seizure like activity during a stim trial early in 2006. No screener settings were altered. Upon permanent device implant, it was noted that product insulation was pulled back on one contact and wires were exposed. The other two contacts were programmed with good efficacy. The lead was not replaced during the case and remains implanted. Impedances were normal; in the 900 ohms range. No report of device explantation has been rec'd.

 
Manufacturer Narrative
Consultation by the rep with the medtronic physician consultant shows the reported seizure like activity can be attributed to postoperative affects and is likely not due to the breach in insulation. An accessory lead cap product is available to the physician for use a staged trail.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=797956
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« Reply #28 on: January 03, 2014, 06:54:09 PM »

Model Number 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
The pt's wife reported to the mfr on 1/16/07, that the pt had recently been experiencing seizures, which have also increased in severity. The spouse stated that episodes of seizure were hardly noticeable before, but now they seem more severe. The spouse also provided that the pt has experienced falls; dates of occurrence were not reported. The pt's wife stated they have contacted the physician specialist who re-directed them to their primary care provider for testing, because the neurologist does not think the seizures are related to the pt's condtion of parkinson's disease. The spouse reported that, the pt has presented for follow-up and testing was performed (no date or exact nature of testing completed was reported), but no determination has been made as to what is causing the change in pt status. The mfr rep re-directed the pt's spouse to contact their physician for add'l medical direction. The mfr has requested more info from the hcp. No report has been received of device explant; the product has not been returned for analysis. The dbs lead was placed in 2002. A follow-up report will be sent if add'l info is received. See mfr report number 2649622200700501.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=818967
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« Reply #29 on: January 03, 2014, 06:55:08 PM »

Model Number 3389
Device Problem Explanted
Event Date 05/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hcp reported the pt experienced headaches and generalized seizures. The pt had bilateral pallidal stimulation due to dystonia. Stimulation was continuous. The pt started to get headaches and seizures soon after the stimulation was turned on. The pt does not have a history of previous seizures. The pt terminated the stimulation at home after the seizures started. A stimulation trail was done and found a clear relation between the seizures and stimulation of the left electrode. The pt responded with localized pain in the left side of the head and a few minutes later a generalized seizure. The seizures improved after turning the stimulation off. The deep brain stimulation had a positive effect on the pt's dystonia. However, the stimulation was terminated due to the seizures and the device was removed. The pt's dystonia deteriorated afterward. The device system was returned to the mfr for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=820833
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« Reply #30 on: January 05, 2014, 02:25:27 PM »

Model Number 3387
Device Problems Intermittent continuity; Kinked; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient was implanted bilaterally in the subthalamus nucleus. The patient was titrated off medication. Initially, it was difficult to capture good efficacy the patient complained of surging and changes in efficacy with palpation at the lead/extension connection. The patient had some tremor control, but not without having foot dystonia or tremor of the upper extremity on the right side. The patient had a thalamotomy effect post-surgery, so the device was not programmed for the patient's left side. The patient was seen by the hcp in 2007. Impedances were checked and no apparent open or electrical shorts were found. The patient was scheduled for exploratory surgery in the following month and put on antibiotics due to higher risk of infection because of diabetes and high hemoglobin aic level. The patient reported during the surgery they found a lead wire that was kinked and the silicone boot was torn near the holding stitch resulting in fluid leaking into the connector boot. The day after surgery, the patient suffered two full-blown brain seizures, unrelated to the deep brain stimulation or parkinsons. The patient claimed he almost died in the hospital and eventually had gall bladder surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900189
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« Reply #31 on: January 06, 2014, 09:01:26 PM »

Model Number 3387 OR 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article.

 
Event Description
Journal reference: kupsch, et al. "pallidal deep-brain stimulation in primary generalized or segmental dystonia. " new england journal of medicine; 2006; 355: p. 1978 - 1990. The article describes the results of a study involving a cohort of patients treated for dystonia with bilateral deep brain stimulation of the internal globus pallidus. Adverse events occurred in patients. Reportable event: one pt experienced a seizure during the randomization phase of the study. The symptoms were generally improved or resolved with changes in stimulation parameters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949258
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« Reply #32 on: January 06, 2014, 09:02:33 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. (see scanned pages).

 
Event Description
Journal reference: kenney, et al. "short-term and long term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. The study describes the results of a retrospective analysis of adverse events in movement disorder patients treated with deep brain stimulation (dbs) at baylor college of medicine between 1995 and 2005 along with a comparison analysis of the medical literature. Reportable event(s): some patients (dbs leads n=4) reported transient seizures post dbs therapy initiation (perioperative period). Treatment info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=951365
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« Reply #33 on: January 06, 2014, 09:03:23 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Disability
Event Description
Journal reference: gill, et al. "deep brain stimulation for parkinson's disease: the vanderbilt university medical center experience 1998-2004" tennessee medicine; 2007; 100: p 45-47. The article presents study results describing the outcomes and adverse event rates from 72 pts followed for an average of 22 months. The pts, all with advanced parkinsons disease, were being treated with unilateral or bilateral deep brain stimulation of the stn. A number of neurostimulation pt complications were reported. Reportable event: one pt experienced an intracranial hemorrhage (confirmed by ct scan) resulting in a permanent neurological deficit with hemiparesis and seizure disorder. Treatment information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949266
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« Reply #34 on: January 08, 2014, 03:50:47 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. Two pts experienced seizures (one each) post dbs surgery. Both pts had cardiovascular risk factors. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002324
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« Reply #35 on: January 08, 2014, 03:51:17 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery and also had transient lung edema. No treatment or outcome info was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002325
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« Reply #36 on: January 08, 2014, 03:52:12 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
See scanned pages.

 
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery. Treatment and outcome info was not provided.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002322
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« Reply #37 on: January 08, 2014, 03:52:42 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: voges, j. , r. Hilker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 pts treated with deep-brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery and also had meningitis. Treatment and outcome info was not provided. Unspecified, likely both unilateral and bilateral systems were used in the study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002275
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« Reply #38 on: January 08, 2014, 03:53:19 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: patel et al. "magnetic resonance imaging-directed method for functional neurosurgery using implantable guide tubes. " neurosurgery 2007; 61 (5, suppl. 2) :358-366. The article discusses an mri-based stereotactic technique that is carried out under general anesthesia. A direct targeting method using high resolution mri with an implantable guide tube that facilitates perioperative verification of target localization and then acts as a conduit to deliver the dbs lead. The technique with the guide tube is described along with an evaluation of its use on 101 pts. A number of complications were included in the article. The guide tube and frame were not manufactured by medtronic. There was one postoperative self-limiting grand mal seizure reported. Treatment and outcome info was not provided.

 
Manufacturer Narrative
Journal reference: patel et al. "magnetic resonance imaging-directed method for functional neurosurgery using implantable guide tubes. " neurosurgery 2007; 61 (5, suppl. 2) :358-366.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1005247
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« Reply #39 on: January 08, 2014, 03:54:15 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: broggi, et al. "deep brain stimulation as a functional scalpel. " acta neurochir suppl 2006, 99:13-19. The article reports on the results of a retrospective study involving the treatment of several drug-resistant neurological syndromes with deep brain stimulation (dbs). A total of leads were implanted in patients. A number of patient complications were reported as part of the study results. Reportable events: three patients (dbs leads n=3) experienced post operative seizures. Treatment and outcome information was not provided.

 
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=939863
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« Reply #40 on: January 08, 2014, 03:56:09 PM »

Event Type  No Answer Provided 
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: goodman r r, kim b, mcclelland s, et al. "operative techniques and morbidity with subthalamic nucleus deep brain stimulation in 100 consecutive pts with advanced parkinson's disease. " journal of neurology, neurosurgery, and psychiatry. Jan 2006; 77(1): 12-7. The article reviewed techniques, efficacy, and morbidity on 100 pts with pd implanted at the hospital/medical center. Sixteen pts had undergone a prior surgery for pd (pallidotomy, thalamotomy, or fetal transplant). Microelectrode guided implantations of the lead (model 3387 or 3389) occurred 1 to 2 weeks before implantation of neurostimulator and extension. Reported events: lead (n=1), neurostimulator (n=1) - 52 year old male pt developed a large subcutaneous haematoma at the pulse generator site. The pt was discharged from the hospital but readmitted the following day because of an episode of decreased mental status. Ct scan demonstrated a frontal lobe infarct in the region of the newly placed electrode. Within 1 day of hospitalisation, the pt had returned to his neurological baseline. Lead (n=1) - a male pt was discharged home 1 day after an uneventful bilateral stn implantation. The following day, he had a seizure and was readmitted. Head ct scan showed a small left frontal lobe haemorrhage and subsequent scans showed no change. The pt was placed on phenytoin (dilantin), had no further seizures, and was discharged in his baseline neurological condition 2 days after his seizure. Lead (n=1), neurostimulator (n=1) - a male pt developed confusion and lethargy 1 month after implantation. Ct scan revealed a left subdural haematoma and further examination revealed an infection at the left pulse generator site. The haematoma was evacuated and the neurostimulator and extension wire were removed with antibiotic treatment. Extension (n=1) - six months later, the pt had a recurrent infection at the residual extension wire and underwent surgery for removal of the residual extension wire, retention of the brain electrode in situ, and antibiotic treatment. Four months later, he had implantation of a new extension wire and pulse generator with uneventful recovery. Neurostimulator (n=3), extension (n=3), lead (n=3) - three pts developed infections which required removal of entire system. Neurostimulator (n=4), extension (n=4) - four pts developed infections which required removal of stimulator and extension. Lead (n=2) - one pt experienced wire breakage/insulation breakdown twice from vigorous scalp massages led to current leakage resulting battery depletion three times. Lead (n=13) - thirteen pts experienced confusion post dbs lead placement. Lead (n=1) - one pt developed an air embolism.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921671
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« Reply #41 on: January 09, 2014, 09:25:39 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: arle et al. "motor cortex stimulation for pain and movement disorders. " neurotherapeutics 2008; 5(1): 37-49. The study involves 15 pts (8 pain and movement disorders, 4 pd, 2 et and 1 cortico-basal degeneration), using motor cortex stimulation. The pt cases were detailed along with a general review and research of literature relative to modeling and understanding the underlying mechanisms of mcs. Reportable event: one pt in the pd group had an intraoperative seizure that was generated during the motor mapping and a focal motor seizure 2 days post.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002334
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« Reply #42 on: January 09, 2014, 09:26:22 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Three of the 15 patients (unspecified) had subsequent hemi-paresis and further secondary complications (pneumonia, pneumonia plus epileptic fits, pulmonary embolism). [see scanned pages].

 
Event Description
Journal reference: voges, j. R. Hilker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occuring during the first 30 postoperative days. A number of patient complications were presented in the article. Intracranial hemorrhages caused neurological deficits in 15 patients (leads n=15). Six patients experienced transient symptoms and 9 patients had symptoms that persisted beyond the 30 day study period. Three of the 15 patients (unspecified) had subsequent hemi-paresis and further secondary complications (pneumonia, pneumonia plus epileptic fits, pulmonary embolism). Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002331
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« Reply #43 on: January 09, 2014, 09:27:39 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description
Journal reference: diamond et al. "problems with deep brain stimulation devices referred to private practice for follow up. " parkinsonism relat disord 2007;13(8 ):520-523. Retrospective review of 9 patients implanted with dbs, initially programmed at other centers and referred to community practice for follow-up. In community practice, patients were re-evaluated, which included review of pre-dbs records, and assessed by movement disorder physician. Pre-dbs diagnosis was subsequently modified for 3 pts. Overall, mean age of 57. 8+/-12. 9 years with age at implantation of 55. 4+/-13. 9 years. Reportable event: of 7 patients who felt they had suboptimal dbs response, 1 patient showed marked functional improvement with reprogramming. This patient also experienced a serious dbs-related intraoperative seizure. No further details were provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991646
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« Reply #44 on: January 09, 2014, 09:28:27 AM »

Model Number 3387
Device Problems Intermittent continuity; Electro-magnetic interference (EMI); Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt's wife reported that prior to the pt's neurostimulator (ins) battery reaching elective replacement, the pt's ins would turn off when the pt would get close to electronic voting (machines), film development kiosks, or computers that were networking. It was also reported that the pt experienced violent seizures in conjunction with the ins turning off in these instances. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992401
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« Reply #45 on: January 09, 2014, 09:29:21 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's wife reported that the patient initially had good therapeutic effect after implant. The patient was in a car accident in 2006. Around the previous month, the patient has had symptoms of slurred speech, confusion, and visual problems. The patient has also had a couple of seizures. In 2007, the patient has had constant migraine headaches with varying severity and duration. The patient's wife reports that due to the patient's symptoms she is worried about leaving her children at home with the patient. The patient's wife also reported that the hcp has been working with them regarding the patient's symptoms, and has done both an x-ray and a ct scan, but no issues were found. The patient's wife alleges that the patient's symptoms are due to the implanted stimulation system. The patient was directed to continue working with their hcp. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982587
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« Reply #46 on: January 09, 2014, 01:52:52 PM »

Model Number 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: wider c, pollo c, bloch j, burkhard pr, vingerhoets fjg. Long-term outcome of 50 consecutive parkinson's disease patients treated with subthalamic deep brain stimulation. Parkinsonsim relat disord 2008;14(2):114-119. The authors describe the long-term outcome in 50 consecutive advanced parkinson's disease (pd) patients treated with subthalamic nucleus deep brain stimulation (stn-dbs). Assessments were carried out at baseline, 6 months, 2 years, and 5 years postoperatively. Stn-dbs is an effective treatment for advanced pd patients, and the beneficial effect is maintained at 5 years. However, worsening occurs over time due to disease progression. Thirty seven patients were available for clinical evaluation at 5 years. Reportable event: one patient presented a generalized epileptic seizure at the time of dura mater opening but before electrode penetration in the brain. Implantation was uneventfully performed 3 weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053668
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« Reply #47 on: January 12, 2014, 06:18:53 PM »

Model Number LEADMVD
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between may 1998 and december 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Eighty one patients had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 patients), misplaced leads (5 patients), intracranial hemorrhage (9 patients), seizures (13 patients), hardware complications (5 patients), other complications (14 patients). Hardware complications: three months after surgery 1 patient presented with a scar and infection in the lead/wire connection site. The whole dbs system was removed and then repositioned at 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019415
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« Reply #48 on: January 12, 2014, 06:19:50 PM »

Model Number 3389
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 02/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt had turned his neurostimulator off because he was going in for a single photon emission computed tomography (spect) bone scan. While the neurostimulator was off, the pt experienced seizures and spasms. The pt was at the clinic and it was recommended that the pt's neurologist be consulted. Additional info has been requested, a follow-up report will be sent if additional info becomes available. See manufacture's report #6000153200801349.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015561
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« Reply #49 on: January 12, 2014, 08:45:55 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic, nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. At 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). Eighty-one pts had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5 pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). One pt experienced small right frontal intracerebral hematoma with convulsions following dbs lead placement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019412
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« Reply #50 on: January 12, 2014, 08:47:14 PM »

Model Number LEADMVD
Device Problems Lead(s), breakage of; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149:867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 727 procedures for the implant of leads in the subthalamic nucleus between may 1998 and dec 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred twenty four pts were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36 - 74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Most pts had no complications, somw pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Fourteen months after surgery, 1 pt had a lead fracture requiring replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019579
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« Reply #51 on: January 12, 2014, 09:01:35 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic, nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. At 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). Eighty-one pts had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5 pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). During dbs lead placement, one pt had transitory intraoperative deterioration of conscious level which forced cancellation of the procedure. Ct revealed a thalamic hemorrhage.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019410
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« Reply #52 on: January 12, 2014, 09:07:48 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Most patients had no complications, some pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Post dbs lead placement, one patient had temporary alteration in personality despite the preoperative behavioral test being normal.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019424
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« Reply #53 on: January 12, 2014, 09:09:01 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Eighty one patients had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 patients), misplaced leads (5 patients), intracranial hemorrhage (9 patients), seizures (13 patients), hardware complications (5 patients), other complications (14 patients). One patient presented with deep venous thrombosis in the lower limbs requiring anticoagulant treatment for 6 months. Unclear when this occurred. No additional information provided.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019423
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« Reply #54 on: January 13, 2014, 02:00:41 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
As a result of an internal audit, this report is being submitted. Literature reference: c hamani, et al. "deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect. Pain. 2006 (125) p188-196.

 
Event Description
Literature reference: c hamani, et al. "deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect. Pain. 2006 (125) p188-196. The article is a retrospective analysis of long-term results of deep brain stimulation (dbs) for the treatment of neuropathic pain on 21 pts. On pt had a seizure in the or during insertion of the deep brain stimulation electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1023416
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« Reply #55 on: January 13, 2014, 02:34:13 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 03/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a brain hemorrhage and a seizure after implant surgery, one month ago. The pt currently suffers short term memory loss.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045342
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« Reply #56 on: January 13, 2014, 02:55:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and december 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Patients had no complications, somw pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Two patients developed urinary tract infections that required antibiotic therapy.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019425
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« Reply #57 on: January 13, 2014, 09:34:35 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. The 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). The pts had no complications, some pts had one complication, some pts had two complications, and two pts had three complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Hardware complications: one month after implant one pt presented with a scar at the wire trajectory which resolved without surgical removal.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019422
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« Reply #58 on: January 13, 2014, 09:35:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. The 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). The pts had no complications, some pts had one complication, some pts had two complications, and 2 pts had three complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Some pts had a post-operative confusional episodes with total resolution within a maximum of 48 hrs.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019420
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« Reply #59 on: January 13, 2014, 09:36:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and late 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Some patients had no complications, some pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Post dbs lead placement, one patient had a small mesencephalic bleed (smaller 0. 5 cm) with convulsions.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019419
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« Reply #60 on: January 13, 2014, 09:36:29 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Patient: are all labeled no. Device: this report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Eighty one patients had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 patients), misplaced leads (5 patients), intracranial hemorrhage (9 patients), seizures (13 patients), hardware complications (5 patients), other complications (14 patients). Four patient experienced seizures and also had bleeding. All seizures occurred within 24 hours lead implant surgery and improved with intravenous phenytoin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019418
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« Reply #61 on: January 13, 2014, 09:37:11 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Patients had no complications, some pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Nine patients experienced seizures with no findings in the routine post operative ct scan. All seizures occurred within 24 hours of lead implant surgery and improved with intravenous phenytoin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019417
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« Reply #62 on: January 13, 2014, 10:12:27 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic, nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implant. At 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). Eighty-one pts had no complications, 41 pts had one complications, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5 pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). Aborted procedures: of 13 aborted procedures, subthalamic nucleus (stn) was not found in 11 pts; the crw frame was disconnected during surgery after the first lead was implanted, which prevented implanting the second lead (1 pt); the neurophysiological recording system failed disabling the left stn and second lead implant (1 pt). Clinical changes were found in 1 pt during the procedure (mild hematoma in right thalamus).

 
Manufacturer Narrative
This report is being submitted following an internal audit.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019409
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« Reply #63 on: January 13, 2014, 10:13:14 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men), who underwent 272 procedures for the implant of leads in the subthalamic nucleus between may 1998 and december 2005. A 4 contrast dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred twenty four pts were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 (4-28 yrs), and the mean f/u was 37 mos (3-93mos). Eighty one pts had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the f/u period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). One pt experienced an intracranial hemorrhage post dbs lead placement resulting in asymptomatic subcortical venous bleeding.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019406
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« Reply #64 on: January 14, 2014, 01:07:27 PM »

Model Number 7426
Device Problem Explanted
Event Date 10/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the device system was explanted, due to seizure activity. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078184
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« Reply #65 on: January 14, 2014, 01:07:57 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The health care professional reported that postoperatively, the pt experienced seizures and had difficulty with gait and speech. The pt spent a month in rehabilitation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1080746
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« Reply #66 on: January 14, 2014, 11:00:06 PM »

Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: merello m, tenca e, lloret sp, et al. Prospective randomized 1-year follow-up comparison of bilateral subthalamotomy versus bilateral subthalamic stimulation and the combination of both in parkinson's disease pts: a pilot study. Br j neurosurg. 2008;22(3):415-422. It has been suggested that potential risk of hemiballismus after subthalamotomy makes dbs preferable to ablation for ipd treatment; however, cost and the need for regular electrode control have also been observed as disadvantages to stimulation. The objective was to compare efficacy and safety of different surgical approaches to stn, in a prospective randomized pilot study. The 16 consecutive ipd pts randomized to receive either: bilateral stn-dbs (bs group), bilateral subthalamotomy (bl group), or unilateral subthalamotomy plus contralateral stn-dbs implantation (l/s group), and followed for 12 months after surgery. Reportable event: one patient from the combined technique group presented a single episode of seizures 7 months after surgery. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161214
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« Reply #67 on: January 16, 2014, 12:51:17 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: paek sh, han jh, lee jy, kim c, jeon bs, kim dg, electrode position determined by fused images of preoperative and subthalamic nucleus deep brain stimulation. Neurosurgery. 2008;63(5):925-937. The electrode position is important to the surgical outcome after subthalamic nucleus (stn) deep brain stimulation (dbs). The aim of this study was to compare the surgical outcome of parkinson's patients of bilateral stn dbs with the electrode position estimated using fused magnetic resonance imaging. Reportable event: seizures developed in 2 patients but were well controlled with antiepileptic drugs. See mfg report #2182207-2008-08567.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273862
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« Reply #68 on: January 17, 2014, 11:43:32 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 11/13/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced an unclear epileptic event. Mri revealed substance around both dbs leads. Fluid was aspirated but upon examination showed no signs of infection; "serile fluid including some old blood". The patient was tested for allergic response to device materials showing no allergy. A second mri showed a decreased volume of the fluid. The patient was scheduled for a follow-up mri the middle of 2008. The relation of the bilateral fluid collection to the implanted devices is unclear. No further epileptic episodes have been reported. The fluid volume is being monitored.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1283182
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« Reply #69 on: January 17, 2014, 07:58:45 PM »

Model Number 7426
Device Problem Explanted
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's device was removed due to infection. The patient symptoms were reported to be drainage, pain, headache, seizure (occurred 2008, with head trauma), nausea, vomiting, and fatigue. The primary location of the infection was the lead track; the patient did not have meningitis. A culture was taken (date not reported) and revealed serratia marcescens; staph coagulase negative. The patient was administered perioperative antibiotics and the infection was treated with iv and oral antibiotics. The infections resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1317789
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« Reply #70 on: January 19, 2014, 10:41:39 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Event Description
The patient was having seizures. There were no known falls or trauma. The patient was directed to his physician. Further information is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1481835
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« Reply #71 on: January 20, 2014, 03:09:42 AM »

Device Problem Device remains implanted
Event Date 05/31/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: romito lm, contarino mf, vanacore n, bentivoglio ar, scerrati m, albanese a. Replacement of dopaminergic medication with subthalamic nucleus stimulation in parkinson's disease: long-term observation. Mov disord. 2009; 24(4): 557-563. Summary: the article reports a long-term prospective evaluation of 20 patients diagnosed with parkinson's disease after bilateral subthalamic nucleus (stn) implants. Patients were evaluated preoperatively and then 6, 12, 18 months and 2, 3, 5 years after the implant. Reportable event: one patient experienced a transient seizure that was responsive to antiepileptic drugs. It was not reported how this was related to the stimulation therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1413203
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« Reply #72 on: January 21, 2014, 01:56:14 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaiem, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: an immediate postoperative ct scan was required in three patients due to repetitve seizures. The results were not reported. No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545846
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« Reply #73 on: January 21, 2014, 02:00:03 AM »

Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l, manninen p, mak p, lukitto k, hodaiem, lozano a. Anesthesia for functional neurosurgery; review of complications. J neurosurg anesthesiol 2006; 18(1):64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: one patient experienced seizures in the early postoperative period. No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545860
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« Reply #74 on: January 21, 2014, 02:03:09 AM »

Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l, manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006,18(1):64-7. Summary: this article presents info from a prospectively collected database on all 186 pts undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implant were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: five pts developed focal seizures during intraoperative stimulation testing that did not require treatment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545814
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« Reply #75 on: January 21, 2014, 02:06:40 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: two patients developed tonic clonic seizures during intraoperative stimulation testing. The patients were treated with and responded to midazolam and/or propofol. After control of the seizures, the remainder of the procedure was successfully completed in all of the patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545824
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« Reply #76 on: January 21, 2014, 02:12:54 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: one patient developed tonic clonic seizures during intraoperative stimulation testing. The patient was treated with 1. 5mg of midazolam which resulted in oversedation and oxygen desaturation. A laryngeal mask airway was inserted to relieve airway obstruction, and the patient was kept asleep for the remainder of the procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545827
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« Reply #77 on: January 23, 2014, 07:56:10 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Life Threatening
Event Description
Literature: susatia f, malaty ia, foote kd, et al. An evaluation of rating scales utilized for deep brain stimulation for dystonia. J neurol. Jan;257(1): 44-58. Summary: the objective of this study was to examine globus pallidus internus deep brain stimulation (gpi-dbs) outcomes in primary and secondary dystonia, derived from blinded ratings using two scales and two raters. Of thirty two patients who underwent dbs surgery at the movement disorder center at (b) (6), twenty five patients met the inclusion criteria and completed the video tape recording within one year post surgery. Event: there were two events of seizure. No further information was provided. See literature article with mfr report #3007566237-2010-03026.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1660262
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« Reply #78 on: January 23, 2014, 07:56:43 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/12/2010
Event Type  Injury   Patient Outcome  Life Threatening
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: ferraye mu, debu b, fraix v, et al. Effects of pedunculopontine nucleus area stimulation on gait disorders in parkinson's disease. Brain. Jan;133(pt 1):205-214. Summary: the study looked at the effects of stimulating the pedunculopontine nucleus (ppn) area in six pts with severe freezing of gait due to parkinson's disease (pd). The pts had been unresponsive to levodopa and subthalamic nucleus (stn) stimulation. Event: one pt displayed two epileptic seizures 1 week after electrode implantation. The pt fully recovered. See literature article with mfr report# 3007566237-2010-02940.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658297
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« Reply #79 on: January 25, 2014, 02:37:36 PM »

Model Number IPG
Device Problem Fracture
Event Date 05/01/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
See also manufacturer report # 3007566237201006838 for related issue. It was reported that the pt had both a deep brain stimulation (dbs) device and a spinal cord stimulation (scs) device implanted on (b)(6) 1981. When the scs device was implanted, it was noted that the lead/extension was fractured. Reimplantation could not be performed due to the presence of scar tissue. The dbs system was then implanted but there was also a lead fracture that occurred within one month of implantation. The leads were, all, left in the pt. In the previous three months, the pt experienced grand mal seizures. No further details, pt symptoms or outcome were provided at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1837229
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« Reply #80 on: January 25, 2014, 02:38:49 PM »

Model Number 37612
Device Problem No Known Device Problem
Event Date 07/21/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
(b)(4).

 
Event Description
Right caudate ischemic event. On (b)(6) 2010, pt had implantation of bilateral dbs for dystonia. In the operating room, it was noted she had slight left sided facial weakness. Post-op mri revealed no acute abnormalities. A small abnormality was seen in right caudate head on diffusion imaging by the dbs team, not noted by radiologist. On (b)(6) 2010, mri was repeated due to facial weakness and flat affect. This mri shows right caudate had ischemia. On (b)(6) 2010, symptoms improved, decrease in left facial weakness, smiling, back to prior alertness and personality. On (b)(6) 2010, she was discharged to home after rapid improvement in her affect and facial weakness. She had evaluations from pt, ot and speech therapy in the hospital and will be scheduled for outpatient therapy if needed.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was in a motor vehicle accident after discharge. The patient returned to the hospital and it was noted that left facial weakness and somnolence remained from the initial post-operative stroke. It was reported that the patient experienced rapid improvement. On (b)(6) 2010 staring spells were noted. The patient was taken off lortab for 24 hours with no difference to staring spells. An electroencephalogram was performed, and the results were reported as abnormal, with some bifrontal sharp waves that might be suggestive of a possible tendency towards seizures. The patient was discharged the following day. On (b)(6) 2010 the patient underwent a ct scan and it was reported that there was no acute intracranial abnormality demonstrated. It was noted that the dbs wires were in unchanged position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888046
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« Reply #81 on: January 26, 2014, 01:39:02 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

 
Event Description
Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
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« Reply #82 on: January 27, 2014, 03:20:51 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/15/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Jonker, p. K. , van dijk, j. M. , van hulzen, a. L. , van laar, t. , staal, m. J. , journee, h. L. The added value of semimicroelectrode recording in deep brain stimulation of the subthalamic nucleus for parkinson disease. Neurosurgical focus. 2013;35(5):e3. Doi: 10. 3171/2013. 8. Focus13289. Summary: accurate placement of the leads is crucial in deep brain stimulation (dbs). To optimize the surgical positioning of the lead, a combination of anatomical targeting on mri, electrophysiological mapping, and clinical testing is applied during the procedure. Electrophysiological mapping is usually done with microelectrode recording (mer), but the relatively undocumented semimicroelectrode recording (smer) is a competing alternative. In this study the added value and safety of smer for optimal lead insertion in the subthalamic nucleus (stn) in a consecutive cohort of patients with parkinson disease (pd) was assessed. Between 2001 and 2010, a consecutive single-center cohort of 46 patients with pd underwent dbs of the stn (85 lead insertions). After exclusion of 11 lead insertions for mostly technical reasons, 74 insertions were included for the assessment. Anatomical target localization was based on either 1. 5-t mri or fused 3-t mri with ct, with reference to anterior commissure¿posterior commissure coordinates. Electrophysiological mapping was performed with smer. Intraoperative clinical testing was dominant in determining the final lead position. The target error was defined as the absolute distance between the anatomical or electrophysiological target and the final lead position. The effect of smer on anatomical target error reduction and final target selection was analyzed. Also, the anatomical and electrophysiological target error was judged against the different imaging strategies. For safety evaluation, the adverse events related to all lead insertions were assessed. The use of smer significantly reduced the anatomical target error from 1. 7 (sd 1. 6) mm to 0. 8 (sd 1. 3) mm (p <(><<)> 0. 0001). In particular, the anatomical target error based on 1. 5-t mri was significantly reduced by smer, from 2. 3 (sd 1. 5) mm to 0. 1 (sd 0. 5) mm (p <(><<)> 0. 001). Anatomical target error reduction based on 3-t mri fused with ct was not significantly influenced by smer (p = 0. 2), because the 3-t mri-ct combination already significantly reduced the anatomical target error from 2. 3 (sd 1. 5) mm to 1. 5 (sd 1. 5) mm compared with 1. 5-t mri (p = 0. 03). No symptomatic intracerebral hemorrhage was reported. Intracerebral infection was encountered in 1 patient following lead insertion. Semimicroelectrode recording has added value in targeting the stn in dbs for patients with pd based on 1. 5-t mri. The use of smer does not significantly reduce the anatomical target error in procedures with fused 3-t mri-ct studies and therefore might be omitted. With the absence of hemorrhagic complications, smerguided lead implantation should be considered a safe alternative to mer. Reported events: 1. One patient experienced an intracerebral infection following a lead insertion which led to bipyramidal syndrome. The patient was reportedly treated with antibiotics and the deep brain stimulation (dbs) system was removed. 2. One patient experienced an intraoperative seizure during final lead placement and the lead insertion procedure was aborted. It was noted that the patient had no lingering symptoms. 3. One patient experienced a superficial wound infection the day following the electrode insertion. The patient was reportedly treated with antibiotics and had no lingering symptoms. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3524080
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« Reply #83 on: January 28, 2014, 09:08:18 AM »

Model Number 7428
Device Problem Invalid sensing
Event Date 12/07/2010
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient experienced a grand mal seizure on (b)(6) 2010. No action was taken. The patient recovered without sequela.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1939241
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« Reply #84 on: February 06, 2014, 10:56:19 PM »

Model Number NEU_INS_STIMULATOR
Event Date 05/29/2012
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

 
Event Description
Piacentino, m. , zambon, g. , pilleri, m. , bartolomei, l. Comparison of the incidence of intracranial hemorrhage in two different planning techniques for stereotactic electrode placement in the deep brain stimulation. J. Neurosurg. Sci. 2013;57(1):63-67. Summary: intracranial hemorrhage is an infrequent but potentially devastating complication associated with the placement of electrodes for deep brain stimulation (dbs). The objective of this retrospective review is to compare the risk of hemorrhage before and after the introduction of image-guided neuronavigation for the implant of electrodes for dbs. We reviewed all dbs implant performed at our institute between 1998 and 2010. In 63 of the 106 patients, the targeting was based on ventriculography and merge of ct/mri. After 2006, in the latter 43 procedures, we introduced targeting based on the merging of angio ct and mri. In both implant techniques, microelectrode recording (mer) was used to better define the target. All dbs procedures were performed by a single surgeon (m. P. ). Patients had postoperative imaging (mri or en 4-24 h following surgery. In the group of patients implanted with the first targeting technique, 3 hematomas occurred and all of them solved with sequelae (one residual weakness and two hemiplegias. ) after the introduction of neuronavigator, 2 hemorrhages occurred, one solved without sequelae while the second resulted in epileptic seizures. Although the incidence of hemorrhage occurred before and after the use of neuronavigation is the same, the severity is lower in the neuronavigated procedures. Targeting based on the merging of ct angiography and mri tl/t2 seemed to increase the safety of the lead placement reducing the risk of sequelae related to bleeding. The use of mer was not found to be correlated with an increased hemorrhage rate. Reported event: one (b)(6) patient with parkinson¿s disease experienced a cortical hemorrhage following deep brain stimulation (dbs) lead implant. The reporter stated that the patient experienced epileptic syndrome as a result of the hemorrhage. It was noted that the patient¿s seizures were well controlled by medical treatment. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3599579
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« Reply #85 on: February 06, 2014, 10:57:48 PM »

Model Number NEU_INS_STIMULATOR
Event Date 07/31/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hung, h. Y. , tsai, s. T. , lin, s. H. , jiang, j. L. , chen, s. Y. Uneven benefits of subthalamic nucleus deep brain stimulation in parkinson's disease-a 7-year cross-sectional study. Tzu chi medical journal. 2013;25(4):239-245. Doi: 10. 1016/j. Tcmj. 2013. 08. 003. Summary: subthalamic nucleus deep brain stimulation (stn-dbs) for motor symptoms of parkinson¿s disease (pd) is promising. However, the benefits of stn-dbs are uneven for the cardinal motor symptoms, as well as for mentality and activities of daily living as the disease progresses. In this report, we will try to clarify which target symptoms have long-term effects during 7 years of stn-dbs. From february 2002 to february 2011, 120 pd patients who underwent stn-dbs were enrolled in this cross-sectional study. Data analysis was performed at postoperative follow-up periods of 1 year, 2 years, 5 years, and 7 years. The unified parkinson's disease rating scale (updrs) was evaluated in four combinations of levodopa/dbs, on/off. With levodopa off/dbs on, the updrs part iii score improved significantly within the 7 years of follow-up (p <(><<)> 0. 001). Decrements in the degree of improvement in axial symptoms were observed after the 5th year. Despite significant improvement in the updrs part ii during the 7 years of follow-up, the score of the schwab and england activities of daily living scale declined after the 5th year of dbs. With levodopa off/dbs off, the scores for part iii and all subitems deteriorated in comparison with the preoperative levodopa off score after the 5th year of follow-up. Bradykinesia was significantly worse in the 5th and 7th years (p <(><<)> 0. 05 and p <(><<)> 0. 01, respectively) and the axial component was significantly worse in the 7th year (p <(><<)> 0. 05). Stimulation side effects included hypophonia (20. 8%), dysarthria (15%), sialorrhea (14. 2%), and decreased memory (14. 2%). Other surgically related adverse effects included intracranial hemorrhage (3. 3%), pulmonary edema (n ¼ 3), deep vein thrombosis (n ¼ 1), seizure (n ¼ 1), depression (n ¼ 7), and mania/hypomania (n ¼ 11). Five electrodes were revised and two devices became infected. Dbs stimulation parameters remained stable except for a significant reduction in frequency in the 7th year. Long-term effects of dbs on motor disability are promising. Dbs showed uneven beneficial effects, and least improvement in axial symptoms and verbal fluency. The disease progressed despite significant positive effects of dbs on the cardinal motor disability symptoms of pd and quality of life at 7 years. Reported events: 1. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and only made a partial recovery. 2. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and made a total recovery. 3. 2 patients with parkinson¿s disease experienced an asymptomatic intracranial hemorrhage. 4. 1 patient with parkinson¿s disease experienced seizures following stn dbs. The reporter stated that the patient recovered well. 5. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device required explant. 6. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device did not require explant. 7. 3 patients with parkinson¿s disease experienced pulmonary edema following stn dbs. The reporter stated that the patients recovered well. 8. 4 patients with parkinson¿s disease had a unilateral lead that was sub-optimally placed and needed to be repositioned. 9. 1 patient with parkinson¿s disease had bilateral leads that were sub-optimally placed and needed to be repositioned. 10. 6 patients with parkinson¿s disease had a wire revision. 11. 2 patients with parkinson¿s disease had battery failure. The reporter stated that the patients had standard stimulation parameters and experienced early termination of the implantable neurostimulator (ins) battery. 12. 1 patient with parkinson¿s disease experienced implantable neurostimulator (ins) migration. 13. 5 patients with parkinson¿s disease experienced lead problems. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3600825
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« Reply #86 on: February 07, 2014, 07:19:10 AM »

Model Number 7428
Event Date 09/06/2013
Event Type  Injury   Patient Outcome  Other
Event Description
Kim, j. W. , hwang, j. H. , kim, i. K. , kim, y. E. , yang, h-j. , ehm, g. , kim, h-j. , kim, d. G. , paek, s. H. , jeon, b. S. Acute brain reaction to dbs electrodes after deep brain stimulation: chronological observation. Acta neurochirurgica. 2013;155(12):2365-2371. Doi 10. 1007/s00701-013-1853-3. Summary: background as increasing numbers of deep brain stimulation (dbs) procedures are performed, rare abnormal findings on postoperative images that are not attributable to well-known complications are reported. Between 2005 and 2012, we encountered several symptomatic patients with transient abnormal low-attenuation lesions on postoperative computed tomography (ct) scans. The aim of this study was to clarify this rare phenomenon using chronological observations and to suggest a feasible mechanism. In this period, seven (3. 2 %) patients displayed transient increased low-attenuation signals, circumferentially surrounding the dbs electrodes and extending into the subcortical white matter. All these patients suffered from unexpected but transient neurological symptoms during the postoperative period. The abnormal low-attenuation lesions only disappeared completely a considerable time after the clinical symptoms had disappeared, without treatment in most patients. We report here our chronological observations of acute brain reactions after dbs procedures, which we believe are neither infectious nor vascular, but are possibly caused by the mechanical breakdown of the blood¿brain barrier by microelectrode recordings or by anchored dbs electrodes. These lesions are thought to constitute a selflimiting disorder requiring no further treatment. Reported event: one (b)(6) female patient with parkinson's disease (pd) experienced a seizure 11 days after deep brain stimulation (dbs) implant surgery. It was noted that the patient had not had any prior seizures. It was noted that the patient had recovered immediately and fully after the dbs procedure with no focal neurological deficit. A ct image showed bilateral low-attenuation lesions around the electrodes and extending into the subcortical white matter. It was noted that the ct image showed no evidence of hemorrhage, infarction, or infection. The reporter stated that the patient was managed with only clinical observation, without treatment. The patient¿s symptoms persisted for 1 day and the duration of the aberrant signal was 23 days. The reporter believed that the acute mechanical blood brain barrier (bbb) breakdown resulting from the brain parenchymal damage during the surgery associated with microelectrode recordings (mer) or by the anchored dbs electrodes was a plausible explanation for the acute brain reaction observed along the white matter tracts of the dbs electrodes. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3554178
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« Reply #87 on: February 07, 2014, 07:27:29 AM »

Model Number 3389S-40
Event Type  Injury   Patient Outcome  Other,Disability,Hospitalization
Manufacturer Narrative
Generalized seizure activity. Concomitant products: product id 3389s-40, lot # va09wn5, implanted: (b)(6) 2013, product type lead. (b)(4).

 
Event Description
It was reported that after the patient¿s leads were placed the ¿subject started having generalized seizure activity. ¿ it was noted the patient was then started on an intravenous antiepileptic drug on (b)(6) 2013. A ct scan of the patient¿s head was performed. The ct scan was ¿negative¿ and indicated the ¿lead placement was correct. ¿ it was noted the patient resolved without sequelae on (b)(6) 2013. It was stated the generalized seizure activity ¿resulted in in-patient hospitalization,¿ ¿prolonged existing hospitalization,¿ and ¿resulted in persistent or significant disability/incapacity. ¿ a supplemental report will be filed if additional information is received.

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« Reply #88 on: March 29, 2014, 12:08:28 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Other
Event Description
It was initially reported that the patient¿s programmer component of their implantable neurostimulator (ins) malfunctioned last week and was working with their healthcare professional (hcp) to obtain a replacement unit (device was at the hcp¿s office). It was also reported that the ins will not turn on using the top button on the side of the recharger unit. A power-on-reset (por) condition on the ins was suspected thought the patient did not report one. The patient could only see the ¿charge complete¿ screen on the recharger and ¿nothing else¿. Additional information received a day later reported that the ins battery in the patient¿s chest was not charging when using the recharger unit. The recharger unit was not working properly and was to be replaced for the patient. Further information received from the patient on (b)(6) 2013 reported that they were able to recharger the ins but was unaware as to how to turn it back on. It was confirmed that the patient¿s programmer unit was at their doctor¿s office and that the batteries had died. The patient stated that they were not supposed to turn of the stimulation from the ins but ¿somehow it turned itself off¿. The patient was able to turn the turn on the stimulation via the recharger unit. It was also reported that the recharger unit ¿failed¿ and did not allow the patient to charge. The last time the patient was able to fully charge was about 4 days ago. The patient could not remember if they had a por condition on their ins or not. The patient reported that the ins was helping with their symptoms but that they did have a seizure. Follow up information received on (b)(6) 2013 confirmed that the patient was sent a new recharger (b)(4) overnight. It was noted that there no further complaints had been received from the hcp¿s office or the patient. It was also believed that the patient was confusing the patient programmer unit with the clinician programmer unit. It was also noted that the programmer unit may have been lost in a fire at the patient¿s home. The patient was given a new programmer at that time and was instructed on its use. In addition, it was reported that there was no evidence that a por condition had occurred on the patient¿s ins device. It was also confirmed that the patient did experience one seizure on (b)(6) 2013 and it was unable to be determined if was due to the recharging difficulties, programming, or was their normal seizure activity. The patient was also re-trained in (b)(6) 2012 for the issue of the having difficulty recharging the device although it was noted that there was a possible failure of the recharger unit. Additional information received on (b)(6) 2013 reported that when the patient pressed the ¿button¿ the stimulation did not turn on. It was noted that the on/off buttons on the recharger were ¿not working¿. In addition, it was reported that the patient had given the programmer unit to the hospital because it would ¿not respond¿. No ¿pictures¿ would come up on the screen event when the patient tried new batteries and troubleshooting. It was also reported that the last time they recharged the ins was 3 or 4 days ago. It was noted that the recharger was charging in the first quadrant. The patient stated that they were part of an experiment for the manufacturer and that they were ¿the only person in the united states with leads in his frontal lobe and a rechargeable ins in his chest¿. The patient reported that the still did not receive a programmer though it was noted that one was sent to them. It was then reported that the programmer unit ¿would not do anything¿, would not turn on or off, and was ¿just blank¿. The antenna locator feature was used tried one more time to ¿activate the stim on/off buttons¿ and the ins was able to be turned on as a result. Information received on (b)(6) 2013 reported that the ¿technical observation¿ revealed that the recharger device was not functioning and that a new one was sent to the patient. The event outcome was reported, as of (b)(6) 2013, as resolved without sequelae. If additional information is received, a follow up report will be sent.

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« Reply #89 on: March 29, 2014, 12:10:06 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient was in the emergency room for seizures. It was noted that the patient went to turn off the implant and patient soon had a seizure after implant was turned off. The implant was turned back on but the patient had aphasia and was having a difficult time speaking but was cognitively there. It was difficult for the patient to get words out at that time. It was noted that this had occurred at 1am on the date of this report. Additional information reported that the manufacturing representative did not have any update. The device was left on and the neurosurgeon was informed of the emergency room visit. It was noted that he did not feel that this was deep brain stimulator related. Additional information was requested but had not been received as of the date of this report. Additional information received reported the healthcare professional did not feel the seizure was related to the deep brain stimulator because, the patient turns stimulation off and on all the time and had never had a problem before. Patient turned stimulation on every morning. It was noted that felt that if it was related to the deep brain stimulator this would have happened before. It was noted that this had only happened once per the staff talked to at the hospital. Manufacturing representative had no information about whether patient had a history of seizures but would contact the healthcare professional to inquire. Additional information received reported the patient had no history of seizures and she had never seen seizures related to a deep brain stimulator implant. Reference manufacturer¿s report number: 3004209178-2014-03023.

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« Reply #90 on: March 29, 2014, 12:11:33 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # j0546569v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 3387-40, lot # j0546401v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 7436, serial # (b)(4), implanted: (b)(6) 2005, product type programmer, patient. (b)(4).

 
Event Description
It was reported that the patient had a loss of therapeutic effect. It was stated that the patient had deep brain stimulation (dbs) therapy for seizure control and had recently started having more seizures. It was further stated that the implantable neurostimulator (ins) was interrogated and was found to be off and, according to the device usage data, had been turned off for several months. It was stated that the ins was then turned on and the amplitude was turned down from 6. 5 volts to 3. 7 volts. It was noted that the patient¿s healthcare provider had not seen the patient in over a year. It was stated that the device had only been used for approximately 67 of the 485 days since the patient had last met with her healthcare provider. It was noted that the patient did not take care of her system, but the people at the assisted living home did. It was further noted that the patient was living at the assisted living home because she had ¿mental issues. ¿.

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« Reply #91 on: March 29, 2014, 12:13:30 AM »

Model Number 7428
Event Date 01/19/2014
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3391, serial# unnknown, implanted: 2013-(b)(6), product type lead. (b)(4).

 
Event Description
It was reported the patient had convulsions. It was noted the event required hospitalization. The patient was noted as being alive with no injury. Symptoms included fever and seizures. It was noted the patient¿s physicians were following up with the situation. The last follow up visit performed with the psychiatrist was done in (b)(6) 2013 and everything was okay. It was later reported the patient¿s stimulator had been off since (b)(6) 2013. It was noted this was an accidental switching off done by the physician. Until the day before the event the patient was fine. It was noted an mri had been planned but the results were not available yet. Follow up reported the patient underwent an mri exam and the results suggested an infection as consequence of sinusitis. The patient was under antibiotics and was being closely followed by the physicians. It was noted at the time the leads and stimulator were still implanted. Additional information reported the entire system was explanted (b)(6), 2014. It was noted the patient was still in the intensive care unit and was unconscious.

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« Reply #92 on: March 29, 2014, 12:15:38 AM »

Model Number 7428
Event Date 01/19/2014
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported the patient had an epileptic seizure (b)(6) 2014. It was noted this was a new illness, injury, or condition that was not related to the device or the procedure. It was noted the situation was evolving at the time and that the patient would see the physician in a couple of days. The severity of the event was noted as severe. The event resulted in in-patient hospitalization and prolonged existing hospitalization. It was a life threatening situation that resulted in permanent impairment of a body structure or a body function. It necessitated medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. It was also noted it resulted in fetal distress, fetal death or a congenital abnormality or birth defect. It was noted as no serious adverse device effect. Additional information reported the patient was awake and able to spontaneously move their limbs. It was also confirmed there was no fetal distress, fetal death or a congenital abnormality or birth defect. It was not known at the time if the event resulted in permanent impairment. The leads and stimulator had been explanted and an infection was detected.

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« Reply #93 on: March 29, 2014, 12:21:16 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 7482a51, serial# (b)(4), implanted: 2007 (b)(6); product type extension product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2004 (b)(6); product type programmer, patient. (b)(4). This device was being used in an clinical trial for the treatment of adult refractory epilepsy.

 
Event Description
It was initially reported that the patient had recently been having some seizures. The patient stated that the patient was a ¿study patient or lab rat if you will,¿ for epilepsy. The patient used to have 5 seizures per day and many grand mal seizures. It was reported that the patient¿s neurologist wanted to remove her implantable neurostimulator (ins), since it did not pass the ¿(b)(4) approval¿. It was noted that the patient needed to have a ¿recharge,¿ but the ins listed for the patient was not a rechargeable type. The patient was told they could have ¿two more charges and that was it. ¿ it was unclear what the patient meant by this. The patient had concerns about what was to happen to their therapy when the battery ran out. It was also noted that the patient ¿donated her memory and half of her right temporal lobe. ¿ the patient also request information on why the deep brain stimulator works so well for their seizures. It was later reported on the same date that the patient had memory loss. The patient stated that half of their right temporal lobe had been removed. The patient stated that during the ¿recharge¿ procedure, lead wires were put to their head and then plugged into the wall. It was noted that this procedure would not recharge the patient¿s implant, as their device was not rechargeable. Additional information received on (b)(6) 2013 reported that the patient had been having a few ¿b and c¿ seizures as of the last six months. The most recent seizure was a ¿c¿ seizure on the ¿(b)(6). ¿ it was unclear which month the patient was referring to. It was noted that the seizures were not as severe as the grand mal seizures they had previous to the deep brain stimulation (dbs) implant. The patient stated that the device had helped them ¿greatly¿ with their epilepsy. Further information received on the same day reported that the patient had ¿about five b or c¿ seizures in the past month. The patient thought that the implantable neurostimulator (ins) battery needed to be replaced because, they had the implant for a long time. The patient indicated that the device was helping with their epilepsy and they wanted the trial to continue. Additional information received on (b)(6) 2013 confirmed that the reported the ins device worked very well for the patient¿s seizures. The patient stated that their healthcare professional (hcp) wanted to take the device out but the patient did not want to have it taken out. Further information received on (b)(6) 2013 reported the patient¿s neurologist wanted to have the ins device removed because, ¿it¿s not working. ¿ the patient thought the ins was working, but the battery was dead but was unsure when it went dead. The patient¿s trial was over and the patient had been having more seizures which was noted as starting up again ¿years ago¿. It was reported that the patient never heard a ¿beep¿ which told them the ins was dead. The patient was told the study they were in had been shut down in was reported as not shut down but was clarified that is was not. Based on evaluations of the patient¿s seizure history over the course of the study (began in (b)(6) 2004), it was reported that their seizures have not improved with stimulation, even before her battery reached end-of-life (eol) and was the reason the hcp recommended explant for her. The hcp felt it was not ethical to continue having her undergo surgical battery replacements if she is not benefitting from the therapy. Additional information received on (b)(6) 2013 reported that the patient was diagnosed with epilepsy and had an increase in seizures since moving and thought the increase in seizures was related to stress. It was noted that the patient¿s current doctor wanted to remove the ins device. The patient did not want to have the dbs therapy removed as they thought it was helping them. It was reported, however, that their doctor was ¿not supporting of that¿. Further information received on (b)(6) 2013 reported that the patient wanted a replacement of the ins device as they felt it was effective in treating their seizures. However, the patient¿s hcp did not want to implant a new one. It was noted that when the patient had a seizure, she had a movement beyond her control, so epilepsy was a ¿movement. ¿ if additional information is received, a follow up report will be sent.

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« Reply #94 on: April 10, 2014, 05:21:37 AM »

Model Number 3389S-40
Event Date 02/03/2014
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0dywx, implanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 37601, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. (b)(4).

 
Event Description
It was reported that the patient seemed confused and not herself after her surgery on (b)(6) 2014. Patient had suffered from a seizure post-surgery. Patient was alive with no injury. Patient symptoms included altered mental status. It was noted that the patient had the generator and extensions implanted on (b)(6) 2014. Programming was to occur 3-4 weeks from the date of this report. Additional information received reported patient would not have initial programming for 3-4 weeks from the date of this report.

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« Reply #95 on: April 10, 2014, 05:22:31 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v499735, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v460686, implanted: (b)(6) 2010, product type: lead. (b)(4).

 
Event Description
It was reported that the patient had 10 ultra sound treatments beforehand and 2 weeks ago had 6 procedures. It was noted that the patient had a loss of therapeutic effect. It was noted that the reporter stated that with all the patient¿s medications the patient lost their balance all the time and fell frequently. It was noted that when the patient fell they did not hit their head and fell on their elbow and broke it. It was noted that the patient also had experienced changes in mental cognitive abilities. It was noted that again it was worse. It was noted that the patient had uncontrollable movements, and made spontaneous drastic movements, with their hands and sometimes hit the wall for furniture. It was noted that the patient had gone to the health care professional (hcp) and was referred for physical therapy. It was noted that the hcp was checking the device. Additional information received reported that the patient recently had an ultrasound and was not feeling well. It was noted that the ultrasound was five days ago and the patient had a convulsion like epilepsy and was shaking. It was noted that the patient had an ultrasound because of the parkinson¿s. It was noted that the patient had hit their elbow and the elbow had a bump so the patient was referred for ultrasound. It was noted that it was therapeutic ultra sound. It was noted that patient had had this before when the weather was changing and was thinking it was maybe the ultrasound procedure. Additional information has been requested, but it was not available as of the date of this report.

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« Reply #96 on: April 10, 2014, 09:40:08 PM »

Model Number 7428
Event Date 08/03/2004
Event Type  Malfunction   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
Product id 3387-40, lot# j0428349v, serial# implanted: 2004 (b)(6); product type lead product id 33 87-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead. (b)(4).

 
Event Description
It was reported the device was turned on at 5 volts for contacts 1, 2, 5, and 6 and the patient had an immediate ¿panic attack. ¿ the device was turned off and restarted fifteen minutes later at the same contacts but at 1 volt. Ten minutes later the patient had a generalized tonic-clonic seizure. The event was noted as ongoing. The event involved in-patient hospitalization. Intervention also included reprogramming. It was noted there was a torqued connection at number 7 revealed by x-rays that were taken to evaluate questionable impedance values. Review of post-operative films showed it occurred at implant. It was also noted that the stimulator was turned off by the patient. The patient had a temporary discontinuation of stimulation. The event was noted as resolved without sequelae.

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« Reply #97 on: June 07, 2014, 11:11:49 AM »

Model Number 37603
Event Date 04/30/2014
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported the patient had gone to the office the day prior to report for a reprogramming session. It was stated no programming had been done yet but the patient had a seizure or stroke in the office. It was stated they did not know if it was related to the device and it was unknown if the patient had a history of stroke or seizure. It was noted the patient was admitted to the hospital and the patient status was unknown. It was further reported the cause of the issue was not determined. It was noted the patient was currently hospitalized.

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« Reply #98 on: June 08, 2014, 01:44:12 PM »

Model Number 7428
Event Date 10/01/2013
Event Type Injury Patient Outcome Other Event Description
Rieu, i. , kombo, m. A. , thobois, s. , derost, p. , pollak, p. , xie, j. , pereira, b. , vidailhet, m. , burbaud, p. , lefaucheur, j. P. , lemaire, j. J. , mertens, p. , chabardes, s. , broussolle, e. , durif, f. Motor cortex stimulation does not improve dystonia secondary to a focal basal ganglia lesion. Neurology. 2014;82:156¿162. Summary: to assess the efficacy of epidural motor cortex stimulation (mcs) on dystonia, spasticity, pain, and quality of life in patients with dystonia secondary to a focal basal ganglia (bg) lesion. In this double-blind, crossover, multicenter study, 5 patients with dystonia secondary to a focal bg lesion were included. Two quadripolar leads were implanted epidurally over the primary motor (m1) and premotor cortices, contralateral to the most dystonic side. The leads were placed parallel to the central sulcus. Only the posterior lead over m1 was activated in this study. The most lateral or medial contact of the lead (depending on whether the dystonia predominated in the upper or lower limb) was selected as the anode, and the other 3 as cathodes. One month postoperatively, patients were randomly assigned to on- or off-stimulation for 3 months each, with a 1-month washout between the 2 conditions. Voltage, frequency, and pulse width were fixed at 3. 8 v, 40 hz, and 60 ms, respectively. Evaluations of dystonia (burke-fahn-marsden scale), spasticity (ashworth score), pain intensity (visual analog scale), and quality of life (36-item short form health survey) were performed before surgery and after each period of stimulation. Burke-fahn-marsden scale, ashworth score, pain intensity, and quality of life were not statistically significantly modified by mcs. Bipolar epidural mcs failed to improve any clinical feature in dystonia secondary to a focal bg lesion. Reported event: one (b)(6) female patient with dystonia secondary to focal basal ganglia lesion had a focal epileptic seizure during the surgery. It was noted that the patient had no history of seizure and had no more seizures since the surgery. The source literature included the following device specifics: ins model 7428 and lead model 3587a further information has been requested; a supplemental report will be submitted if additional information is received.
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id 3587a, lot# unknown, product type: lead. (b)(4).

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« Reply #99 on: July 04, 2014, 09:03:59 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Event Description
Schmitt, f. C. , voges, j. , heinze, h. J. , zaehle, t. , holtkamp, m. , kowski, a. B. Safety and feasibility of nucleus accumbens stimulation in five patients with epilepsy. Journal of neurology. 2014. Doi: 10. 1007/s00415-014-7364-1 summary: in five adult patients with intractable partial epilepsy, safety and feasibility of chronic bilateral electrical stimulation of the nucleus accumbens (nac) were assessed, also providing initial indications of therapeutic efficacy. Concurrent medication remained unchanged. In this phase 1 trial, clinical outcome parameters of interest were quality of life in epilepsy questionnaire (qolie-31-p), beck depression inventory, mini international neuropsychiatric interview, neuropsychological testing, and liverpool seizure severity scale. Those data were obtained after 6 months of nac stimulation and compared to the equivalent assessments made directly before implantation of electrodes. Additionally, monthly frequencies of simple partial seizures, complex partial seizures (cps), and generalised tonic¿clonic seizures (gtcs) were assessed during 3 months before electrode implantation and at the end of 6-month nac stimulation. Proportion of responders, i. E. C50 % reduction in frequency of disabling seizures (sum of cps and gtcs), was calculated. Main findings were unchanged psychiatric and neuropsychological assessment and a significant decrease in seizure severity (p = 0. 043). Qolie-31-p total score trended towards improvement (p = 0. 068). Two out of five participants were responders. The median reduction in frequency of disabling seizures was 37. 5 %. In summary,we provide initial evidence for safety and feasibility of chronic electrical stimulation of the nacin patients with intractable partial epilepsy, as indicated by largely unchanged neurocognitive function and psychiatric comorbidity. Even though our data are underpowered to reliably assess efficacy, the significant decrease in seizure severity provides an initial indication of "antiictal" efficacy of nac stimulation. This calls for larger and at best randomised trials to further elucidate efficacy of nac stimulation in patients with pharmacologically intractable epilepsy. Reported event: a 53 year old female did not respond to stimulation of the nucleus accumbens. The patient also reportedly had an increase in total number of psychiatric conditions from 0 to 2; and included new onset generalized anxiety disorder after 6 months and major depression. Stimulation also had to be turned down in this patient due to an abrupt increase in seizure frequency. Additional information has been requested but was not available as of the date of this report.
Manufacturer Narrative
Concomitant product: product id 3387, lot# unknown, product type lead. (b)(4).

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« Reply #100 on: July 05, 2014, 12:17:17 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was reported the patient was getting ¿zapped¿ in their head at the time of report. It was stated it had been going on for 2 years prior to report. It was noted a few weeks prior the patient started to have seizures more often and they thought the device might have contributed to that. It was stated the patient fell more often and they were losing strength in their legs.
Manufacturer Narrative
Product id: 3387-40, lot# j0104141v, implanted: (b)(6) 2001, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. (b)(4).

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« Reply #101 on: July 05, 2014, 12:18:07 AM »

Model Number 7426
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported that the patient had blacked out on monday prior to the date of this report. It was noted that the patient had episodes of dystonic seizures that lasted 45-50 seconds. It was further noted that the patient had blacked out a few times since monday prior to the date of this report. It was noted that someone at the hospital thought the right implant had a short. The patient would not get the device reset or checked for 2 weeks. The patient fell 2 months prior to the date of this report but they did not think this was related to the current incident. Patient¿s status was unknown. The patient was admitted to the hospital. It was later reported that the patient was ¿having seizures because of a faulty unit. ¿ this had started monday (b)(6) 2014. Therapy was not working as expected. There was a loss of therapeutic effect. Additional information received reported the patient was still having concerns with their device or therapy but was working with their doctor or manufacturing representative. The patient had an appointment on (b)(6) 2014. Reference manufacturer¿s report number: 3004209178-2014-09986.
Manufacturer Narrative
Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387, serial# (b)(4), implanted: (b)(6) 2007, product type: lead; product id 7438, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v805902, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

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« Reply #102 on: August 11, 2014, 11:12:14 AM »

Model Number 7428
Event Type Injury Patient Outcome Hospitalization,Other
Manufacturer Narrative
Concomitant medical products: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product: id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2007, product type: lead. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2007, product type: lead. (b)(4).

Event Description
It was reported that the patient had been having a problem with seizures in (b)(6) 2014. The patient was in the hospital (b)(6) 2014. The implantable neurostimulator (ins) was turned off at that time because the healthcare professional thought that it could be impacting seizures. It was noted that turning the ins off had not taken care of the issue and had not appeared to be related. Stimulation was turned off in (b)(6) and had not been turned on because the patient had not been alert enough to answer if stimulation was helping and it was too much trouble to travel to turn the ins on and set up programming.

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« Reply #103 on: September 06, 2014, 12:53:49 AM »

Model Number 37603
Event Date 01/22/2014
Event Type Injury Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient experienced seizure like episodes. It was noted that the outcome was ongoing. It was noted that diagnostic methods included ct scan with contrast showing small amounts of blood around mid-portion of left dbs electrode. It was noted that the etiology was surgery/anesthesia. It was noted that the event was not related to the device or therapy. It was noted that the event was related to the implant procedure. It was noted that during the event the patient¿s armed flexed and began expressing gurgling sounds. It was noted that the ct reveled a small amount of blood around mid-portion of left dbs electrode in basal ganglia. It was noted that the severity was severe. It was noted that the event resulted in in-patient hospitalization. Additional information received reported that the seizure like episode occurred during the operating procedure. It was noted that the entire system was removed on (b)(6) 2014. Additional information received reported that the patient was having his system replaced when the event occurred. It was noted that the patient had not had the implantable neurostimulator (ins) placed yet. Additional information received reported acute hemorrhage around the left electrode. It was noted that after recovering the patient¿s implantable neurostimulator (ins) was implanted on (b)(6) 2014. It was noted that interventions included medical or non-surgical therapy including a regular textured diet. It was noted that the medical or non-surgical intervention was pharmacological. It was noted that eeg results were negative. It was noted that a ct scan with contrast showed that the patient was stable.
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3977510
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« Reply #104 on: September 06, 2014, 01:52:28 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979081
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« Reply #105 on: October 12, 2014, 12:49:52 PM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id n eu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension. (b)(4). Age at time of event: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.

Event Description
Tolleson, c. , stroh, j. , ehrenfeld, j. , neimat, j. , konrad, p. , phibbs, f. The factors involved in deep brain stimulation infection: a large case series. Stereotactic and functional neurosurgery. 2014;92(4):227-233. Doi: 10. 1159/000362934. Summary: deep brain stimulation (dbs) is a proven treatment for various movement disorders resistant to medical management. Complications such as postsurgical infection can negate benefits and increase patient morbidity. We sought to better define risk factors for infection. We performed a review of dbs cases at our institution from january 1996 to june 2011. Information on multiple metrics including surgical complications, procedural complications and infection were entered into a secure online database. A total of 447 patients received dbs surgery. Twenty-six (5. 82%) developed infection sometime after dbs surgery with 9 (2. 01%) developing infection within 30 days after the final staged surgery. Operating surgeon (p = 0. 012), scalp erosion (p = 0. 0001), surgical incision opening time (0. 0001) and number of individuals in the operating room (0. 0027) were significant in the cumulative infection group. The 30-day infection rate was comparably low to other published studies. Several factors were noted to be significant in the cumulative infection group, but none in the 30-day infection group. Further understanding of infection risk factors is important to optimize patient selection and standardize infection-preventative techniques. Reported events: 1. 1 patient experienced a seizure. 2. 2 patients experienced intracranial hemorrhages. 3. 1 patient had a prolonged length of stay of 48 hours; it was noted that the normal stay was overnight. 4. 1 patient required multiple revisions. The reason for revision was not noted. 5. 2 patients experienced lead migration. 6. 2 patients experienced lead and implantable neurostimulator (ins) malfunction. 7. 1 patient experienced a small hemorrhage and bilateral pulmonary embolus. 8. 4 patients experienced the extension wire tethering/retunneling. 9. 26 patients developed infection after deep brain stimulation (dbs) surgery. It was noted that these 26 patients had a total of 38 discrete infection episodes. There were 8 patients who had repeat infections; 6 patients had two episodes of infection and 2 patients had four episodes of infection. The reporter stated that 9 patients had occurrence of infection within 30 days of surgery, 4 patients had occurrence of infection between 30 and 60 days, 2 patients had occurrence of infection between 60 and 90 days, and 11 patients had occurrence of infection after 90 days post-surgery. It was noted that cultures were taken for 30 of the infections. Reportedly, there were 12 staphylococcus aureus infections, 4 methicillin-resistant staphylococcus aureus infections, 4 enterobacter, 2 pseudomonas, 1 serratia, 2 staphylococcus coagulase-negative, 2 mixed and 3 no growth infections. The reporter stated that out of the 38 instances of infection, 1 infection received only antibiotics, 7 received antibiotics plus a surgical exploration of the wound, which would include a washout and/or moving of parts of the apparatus. Reportedly, 10 of the infections received antibiotics plus total removal of the hardware and another 3 received antibiotics plus removal of an entire side of the dbs apparatus when a dual channel was used. It was noted that the other 17 had local removal of hardware. Only 1 of the 8 patients with repeat infection had only antibiotics and a washout as the first intervention. 5 patients had infection of the scalp overlying the lead, 6 patients had infection overlying the extension, 6 patients had primary infection of the implantable neurostimulator (ins), 2 patients had infection of the lead/extension, 1 patient had infection of the ins/extension, 4 patients had infection of the entire apparatus, 1 patient had infection of the bony markers, and 1 patient had infection of the lead/opposite side ins. It was noted that there were 11 infections which had a primary infection involving the ins, of these infections 6 involved kinetra model 7428, 2 involved activa pc model 37601, and 3 involved soletra model 7426. 10. 1 patient had an intracerebral abscess. 11. 1 patient experienced cancer near the burr holes. The source literature included the following device specifics: the leads were model # 3387 or 3389, and extensions were model # 7495 or 7482a-s1. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4090384
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« Reply #106 on: October 13, 2014, 03:39:03 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had had seizure on two separate occasions post deep brain stimulator implant. Prior to the deep brain stimulator surgery the patient had never had a history of seizures. The first seizure had occurred on (b)(6) 2014 and the patient was taken to the hospital after the seizure where a computerized axial tomography scan (cat) was performed and nothing was found. The second seizure event occurred on (b)(6); the patient had a seizure and was taken to the hospital. While the patient was in the emergency room, she had another seizure when she had gotten up to walk to the restroom. The patient had smashed her face and broke her leg which had resulted in hospitalization and surgery on the leg. The patient was in physical therapy for two weeks. The patient is now on anti-seizure medication, keppra-anti which is an epileptic drug. It was noted that since the patient had started the drug she had not had another seizure. All seizure events had occurred while the deep brain stimulator was off, the patient had never been turned on. (b)(6) 2014 was the first time, the patient had stimulation turned on. The patient had unilateral implant on the left side for a right side tremor. Following programming on the date of this report there was no visible tremor and the deep brain stimulator was working fine. There was good tremor control. The patient was scheduled for a follow up appointment in two weeks from the date of this report.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead. (b)(4).

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« Reply #107 on: November 08, 2014, 08:21:06 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va07ll1, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
It was reported that the device was never really effective. The patient had gone to their healthcare professionals in (b)(6) 2013 for programming and they had been unable to get the device programmed. The patient was told that it needed to heal. In (b)(6) 2013 the patient had gone back in for programming, stimulation was turned up high to try to program the device but when they had turned it up high the patient had had a seizure and fractured his back. The patient had had the seizure because the wire had come loose and was sitting on the part of the patient¿s brain that caused seizures. The patient¿s health has prevented the patient from going back for programming. The patient¿s hands shook and he was unable to pick stuff up. No outcome was provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

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« Reply #108 on: January 04, 2015, 12:14:42 AM »

Model Number 37601
Event Type Injury
Event Description
Bucurenciu, i. , staack, a. M. , hubbard, i. , rona, s. , gharabaghi, a. , steinhoff, b. J. Coincidence of non-convulsive epileptic seizures and electrical stimulation of thalamic anterior nuclei in an epileptic patient. Clinical neurophysiology: official journal of the international federation of clinical neurophysiology. 1388;2014 sep 2. Doi: 10. 1016/j. Clinph. 2014. 08. 008. Summary: a recent randomized, prospective study showed that deep brain stimulation (dbs) of anterior thalamic nuclei (ant) reduced frequency and intensity of epileptic seizures in medically refractory partial seizures, including secondarily generalized seizures ((b)(4)). Stimulation-associated transient seizures have been reported up to now in two patients ((b)(4)). In none of these cases a detailed description of the epileptic syndromes, of the electro-clinical semiology of stimulation-associated seizures and of the exact time-correlation between ant-stimulation and seizures onset and duration was provided. Therefore, mechanisms behind the effects and even the causality remain unclear. A detailed analysis of such cases might establish whether stimulation-associated seizures depend on epileptic syndromes and/or on stimulation parameters, and might give insights into the mechanism of action of dbs. We report the first case where the ant-stimulation intervals were precisely resolved and demonstrate for the first time a coincidence between on-phases of stimulation and habitual epileptic seizures, strongly suggesting a causal relationship. Reported events: one (b)(6) female patient was implanted with bilateral deep brain stimulation (dbs) of the anterior thalamic nuclei (ant) to treat non-lesional, medically refractory epilepsy of unclear etiology. The reporter stated that mutism and avolition after onset of dbs were interpreted as disappointment of the patient, since her habitual tonic-dyscognitive seizures were not improved by ant-dbs. The patient¿s scalp-eegs were closely reanalyzed towards the end of 11 months of dbs. Retrospectively and prospectively, the on-phases of stimulation cycles could be regularly identified based on amplitude reductions of qrs-complexes in electrocardiograms. The morphology of habitual bilateral fronto-centro-temporal (sharp)-slow-wave discharges in eegs was unaffected by ant-dbs. It was noted that there was a time-correlation between on-phases of stimulation cycles and habitual subclinical seizures at stimulation equal or above 3v. Repetitive bursts of sharp-slow-waves occurred 12. 6 seconds after onset of ant-dbs, which was similar to the time needed for ant-dbs to affect neocortical temporal activity. Electrical activity ceased 21. 7 seconds after the end of stimulation-on phases. In the density-spectral-array of a long-term video-eeg, several regularly-occurring periods with dominant delta frequencies, corresponding to bilateral anterior (sharp)-slow-wave series, were identified during ant-stimulation phases. In video-eeg-recordings performed when the patient was reading aloud, eeg-discharges accompanied by interruption of reading flow were reproducibly documented during on-phases of stimulation cycles. Ant-dbs was discontinued at the patient¿s request. The source literature included the following device specifics: lead model 3389 and activa pc ins model 37601 further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events. The device was used for an off label indication as it was implanted to treat seizures. Concomitant: product id 3389, lot# unknown, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4219411
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« Reply #109 on: January 10, 2015, 12:46:29 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant: product id 3389, lot# unknown, product type lead. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 3389, product type lead. Product id 7428, product type implantable neurostimulator. (b)(4).

Event Description
Chiou, s. M. , lin, y. C. , lu, m. K. , tsai, c. H. Bilateral subthalamic stimulation for advanced parkinson disease: early experience at an eastern center. Neurological sciences : official journal of the italian neurological society and of the italian society of clinical neurophysiology. 2014. Doi 10. 1007/s10072-014-2008-x summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) can improve the life quality of patients with advanced parkinson disease (pd). However, previous studies have stemmed mainly from (b)(6). Present study analyzed the 6-month outcomes of bilateral stn-dbs therapy that were observed during a 9-year period at a (b)(6). We retrospectively reviewed 72 consecutive patients, whose mean disease history was 8 years when they underwent surgery. The median ¿¿drug-off¿¿ hoehn and yahr stage was 3. The stn was targeted using t2-weighted magnetic resonance imaging and electrophysiological guidance. The over-time mean differences in the unified pd rating scale (updrs) scores and daily levodopa-equivalent dose (led) were assessed using the repeated measurements anova at 3 and 6 months relative to those of presurgical drug-off baseline. At 6 months postsurgery, the mean updrs total, part ii and part iii subscores significantly decreased by 27, 30 and 25 %, respectively, with clinically high effect size. Tremors were markedly (66 %) ameliorated. Moreover, problems of akinesia, rigidity, and locomotion were significantly improved by 20 %. The mean daily led needs decreased by 25 %; thus, drug-induced dyskinesia was markedly (80 %) diminished. Stn-dbs therapy could provide similarly effective impacts to eastern and western pd patients. Preoperative optimal selection of patients and postoperative delicate programming ensure a better surgical improvement. Reported events: two patient with deep brain stimulation (dbs) for parkinson¿s disease experienced a seizure the day after implantation. It was noted that the patient subsequently exhibited a smooth treatment course. Two patients with dbs for parkinson¿s disease had malpositioned right leads, which were relocated when the implantable neurostimulator (ins) was implanted. It was noted that the patients subsequently exhibited a smooth treatment course. Two patients with deep brain stimulation (dbs) for parkinson¿s disease experienced acute psychosis for 3-4 days. It was noted that the patients subsequently exhibited a smooth treatment course. One diabetic patient with dbs for parkinson¿s disease experienced fluid accumulation in the chest ins pocket within one week; therefore, the ins was removed immediately and re-implanted four months later. It was noted that the patient subsequently exhibited a smooth treatment course. The source literature included the following device specifics: lead model 3389 and kinetra ins model 7428 further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4376136
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« Reply #110 on: January 10, 2015, 12:47:22 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had been having massive headaches that triggered seizures. This had been going on for about two years and it was getting progressively worse. The patient was having an mri of the brain and cervical spine the day after this report. The patient¿s programmer was lost, but the patient stated their healthcare professional (hcp) had a device to turn the implantable neurostimulator (ins) off. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant: product id 3708660, serial# (b)(4), implanted: 2014-(b)(6), product type extension. Product id 3387-40, lot# j0104141v, implanted: 2001-(b)(6), product type lead. Product id neu_ptm_prog, product type programmer, patient. (b)(4).

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« Reply #111 on: January 10, 2015, 12:48:15 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v081575, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v081575, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

Event Description
It was reported 4 days after implant the patient had a seizure and stopped breathing. They were different than the ones he would have before when ¿he would swallow. ¿ the patient had two other seizures on (b)(6) 2014 and (b)(6) 2014. They would see ¿bright lights like fireworks¿ and the patient had fallen out of their bed as well. They were not sure how that happened since ¿their feet were where his head should have been and they did not know how he had gotten in such a small space. ¿.

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« Reply #112 on: January 10, 2015, 12:49:11 AM »

Model Number 7426
Event Date 10/12/2014
Event Type Injury
Event Description
It was reported that ¿every time¿ the patient¿s hippocampal implantable neurostimulator (ins) was turned on, the patient ¿had seizures. ¿ the patient had reportedly been seizure free ¿for a long time,¿ however, the patient¿s seizures had recently ¿come on strong after being exposed to electromagnetic interference¿ (emi). The emi (at a security screener gate) was reported to have turned the patient¿s ins on. This event had occurred on (b)(6) 2014. The ins was turned off following the event. The patient was ¿seizure free for four weeks until (b)(6) 2014 when they had seizures again and fell. ¿ as a result, the patient ¿had to go to the hospital for assistance. ¿ it was noted that at that time ¿they thought the patient was having a stroke. ¿ the patient ¿hadn¿t had another event since (b)(6) 2014 when the hospital reprogrammed the implant to be at 0 volts, so if it came back on accidentally, it would come back on at 0 volts. ¿ the patient reportedly experienced ¿anxiety around emi because of the event¿ and ¿wanted the implant removed for peace of mind. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Please note, this device was used for an off label indication. (b)(4).

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« Reply #113 on: January 10, 2015, 03:53:17 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3387s-40, lot# v130906, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3387s-40, lot# v130906, implanted: (b)(6) 2008, product type lead. (b)(4).

Event Description
It was reported that the patient was having seizures and it was unknown why. They had not thought that the seizures were related to the deep brain stimulator therapy. The patient was not having ¿full blown¿ seizures, only partial seizures. The patient had been having these for the past 4-5 weeks prior to the date of this report. The patient¿s healthcare professional wanted to do an electroencephalography (eeg) to see if they could find the cause of the seizures. The patient had been in the emergency room on (b)(6) 2014 and again on monday and tuesday prior to the date of this report because he had not been feeling well. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334477
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dennis100
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« Reply #114 on: January 10, 2015, 05:25:10 AM »

Model Number 3387S-40
Event Type Injury
Event Description
It was reported the patient experienced a seizure approximately nine days after bilateral globus pallidus internus lead implants. There were no alleged product issues and no actions were required as a result of the event. The patient status at the time of this report was alive with no injury. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0nfax, implanted: (b)(6) 2014, product type: lead. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318458
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dennis100
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« Reply #115 on: January 10, 2015, 08:43:14 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient started having symptoms of dementia in (b)(6)¿ (b)(6) and the patient had two seizures in february that accelerated the dementia. The patient recently saw a healthcare professional (hcp), but they do not work with deep brain stimulation therapy. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300829
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dennis100
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« Reply #116 on: January 10, 2015, 08:43:56 AM »

Model Number 37601
Event Date 11/10/2014
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) ; product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

Event Description
It was reported, the patient had a seizure monday night post operation and again on the day of this report. The patient had swelling and edema near the site of the contacts by one of the implanted leads. The implantable neurostimulator (ins) had not been programmed or turned on after implant. Impedances were run during the operation. A ct scan was done and the cause of the event was unknown. The patient was still in the hospital and the device was not on. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4298457
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dennis100
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« Reply #117 on: May 09, 2015, 02:44:05 AM »

Model Number 3387S-40
Event Type Injury
Event Description
It was reported that the patient¿s stage 2 procedure was cancelled due to him having a seizure the day prior. His leads were implanted one week prior and he was admitted to the hospital the monday prior to the report, where had another seizure. A ct scan came back normal and the patient did not have a history of seizures. He was evaluated by neurology and there was no permanent impairment. He was doing fine and scheduled for stage 2 surgery on (b)(6) 2015.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va0s7rt, implanted: (b)(6) 2015, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702383
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« Reply #118 on: June 08, 2015, 06:10:47 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had a seven year history of parkinsonism complicated by high dose use of entacapone and levodopa. The patient's implant of the system in the subthalamic nucleus was complicated by right frontal hemorrhagic stroke with bi-frontal injury evident on ct. The stroke resulted in left sided paresis and cognitive dysfunction amplified by two seizures. The patient was treated at ucsf. The patient was doing well with isolated control of parkinsonism and their health care professional (hcp) was monitoring their cognition.

Manufacturer Narrative
Concomitant products: product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755853
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« Reply #119 on: June 08, 2015, 06:11:26 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v010169, implanted: (b)(6) 2006, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v010169, implanted: (b)(6) 2006, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

Event Description
It was reported the patient had a seizure and was in a hospital in (b)(6). A manufacturing representative later reported the patient was back in the united states and they continued to have seizures. The patient¿s healthcare professional (hcp) had not determined if the implantable neurostimulator (ins) was contributing to the seizures. The patient was scheduled for an mri next week. The patient was receiving effective therapy at the time of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4798705
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dennis100
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« Reply #120 on: July 15, 2015, 11:51:30 PM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant product(s): product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# l75839, implanted: (b)(6) 2000, product type lead: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# va01k4q, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported the patient has had seizures since (b)(6) 2014. The seizures were not a pre-existing condition and during the last two months the seizures had increased in frequency. The seizures lasted about 10 to 15 seconds. Two days prior to this report the patient had six seizures in a row with about a 20 second break in between. The patient was taken to the emergency room and a ct scan was done, but there was not enough detail to determine the cause. The patient had a right lead replaced in 2010 or 2011. An appointment with the patient¿s healthcare professional was scheduled for the day of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-11827.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4853505
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dennis100
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« Reply #121 on: August 08, 2015, 09:51:20 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported the patient had increased seizures on stressful days, tension from work and a new location, and anxiety. It was also reported etiology was programming/stimulation; vibration when stimulation was on and stopped. On (b)(6) 2010, therapy was suspended. Stimulation was turned off at night via ¿atc. ¿ on (b)(6) 2010, the patient was reprogrammed two minutes on and one hour off; it was also reported therapy was suspended. On (b)(6) 2010, the patient was reprogrammed; returned to cycling parameters of two minutes on and one hour off. It was also reported therapy was suspended on june 3. On an unknown date an intervention was performed of temporary direct current of stimulation via ¿atc. ¿ on (b)(6) 2010, therapy was suspended. On (b)(6) 2010, the patient was reprogrammed from 2 volts, pulse width of 120, 2 minutes on and one hour off to 3 volts, pulse width of 150, 2 minutes on and 0. 5 hours off; it was also reported therapy was suspended. It was noted there were no hospitalizations related to this event. The event was ongoing.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7436, serial # (b)(4), implanted: (b)(6) 2004, product type programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4931734
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« Reply #122 on: September 07, 2015, 07:59:01 AM »

Model Number 7428
Event Type Injury
Event Description
The patient reported that she had two seizures and they only happened when she was using her patient programmer. The first occurred in (b)(6)2015 and the other occurred on (b)(6) 2015 when someone was checking the 9 volt battery in the programmer. Her indication for use was other. No interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown_lead, product type: lead. Product id: neu_ptm_prog, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5005173
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