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Author Topic: Deep brain stimulator - Seizures  (Read 49640 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 Dopamine agonists were withdrawn one week before surgery and levodopa the evening before.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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« 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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