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Author Topic: Deep brain stimulator - Speech  (Read 85610 times)
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dennis100
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« on: November 05, 2013, 11:45:10 PM »

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 03, 2014, 02:48:13 AM by dennis100 » Logged
dennis100
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« Reply #1 on: November 05, 2013, 11:45:35 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/29/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: holl em, peterson ea, foltynie t, et al. Improving targeting in image-guided frame-based deep brain stimulation. Neurosurgery. Dec 2010; 67 (2 suppl operative): 437-447. Summary: pre- and postoperative stereotactic magnetic resonance images (mri) were analyzed in 165 pts with parkinson disease (pd). The perpendicular error between planned target coordinates and electrode trajectory was calculated geometrically for all 312 dbs electrodes implanted. Improvement in motor unified pd rating scale iii subscore was calculated for those pts with pd with at least 6 months of f/u after bilateral subthalamic dbs. Reportable event: one pt (pt 2 of 2) with bilateral stn dbs electrodes underwent delayed repositioning of the left electrode to a more posterolateral location after he experienced gradual deterioration in stimulation efficacy and in speech articulation. See literature article with mfr report# 3007566237201101161.
 
Manufacturer Narrative

(b)(4) - deterioration in speech articulation. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. 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 regarding the device, the event and pt outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000249
« Last Edit: February 03, 2014, 02:48:43 AM by dennis100 » Logged
dennis100
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« Reply #2 on: November 05, 2013, 11:45:59 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/14/2010
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

Literature: boon p, dandachi-fitzgerald b, duits a, temel y, visser-vandewalle v, van den hout m. Modification of emotional states by bilateral stimulation of the subthalamic nucleus in a patient with parkinson's disease. J neurol neurosurg psychiatry. January 2011;82(1):117-118. Summary: the authors report on one parkinson disease patient who was successfully treated with bilateral subthalamic nucleus (stn) stimulation but showed postoperative gradual worsening of the psychological status. By using a single case experiment design (sced), the authors attempted to find out whether these problems were stimulation-related. Reportable event: the authors reported a (b)(6) woman with a 13-year-old history of pd with a slight depressive elevation. Psychiatric evaluation, however, revealed no psychopathology. The patient underwent a one-staged bilateral stereotactical implantation of electrodes and was discharged with stimulation at pole 1 monopolar, pulse width 90 ms, frequency 130 hz, 1. 5 v right and 1. 2 v left. In the 20 months following surgery, stimulation was adjusted up to 3. 0 v bilaterally to optimize motor function. During follow-up at 3, 6 and 12 months postoperatively, the patient increasingly complained of various psychological symptoms including depression, emotional instability and altered self perception. In addition, she reported a slow and unnatural speech. All these complaints interfered with her daily life, leading to social unease and marital problems. Depression scores increased after initial improvement to clear depression at the last follow-up. Neuropsychological assessment (with medication and stimulation on) showed no significant changes compared with preoperative assessment. Stimulation was never turned off for 12 h or more. After counseling in our institute, we referred the couple to marital therapy. Almost 2 years after surgery, she was admitted to our hospital, because her complaints had reached a crisis. After the neurostimulator was turned off for 12 h, she reported improvement in mood and speech however, severe motor symptoms recurred. Overall stimulation and medication adjustments were made and the patient reported that final adjustments to her regiment were most acceptable for her.
 
Manufacturer Narrative

(b)(4) altered self perception; slow and unnatural speech; social/marital unease. (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 regarding the patient and the event has been requested.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2028308

« Last Edit: February 03, 2014, 02:49:58 AM by dennis100 » Logged
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« Reply #3 on: November 05, 2013, 11:46:22 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

Literature: ali z, prabhakar h, rath gp, dash hh. Enoxaparin induced intracerebral haemorrhage after deep brain stimulation surgery. Eur j anaesthesiol. Jul 2009:26(7):617-618. Summary: this article discussed a case of anticoagulant (enoxaparin) induced intracerebral hemorrhage in the post-operative period in a (b)(6) male parkinson's disease pt who underwent bilateral subthalamic nucleus deep brain stimulation (stn-dbs) surgery. The pt had a history of tremulousness of the right upper limb and both lower limbs associated with sluggishness of movements, decreased volume and slurring speech for three years, after which over a period of 6 months, the pt's symptoms progressed and examination revealed hypertonia, bradykinesia, rigidity, and postural instability. The pt also had a history of hypertension, coronary artery disease, and subdural hematoma. Event: following the second stage of the stn-dbs surgery during which the stimulator was implanted and during which the pt had mechanical ventilation, the pt's trachea was extubated and the pt was moved to the icu. On the fifth post-operative day, 40 mg of enoxaparin was administered to prevent deep vein thrombosis. The pt became unresponsive within a few hours of administration. The pt was reintubated and taken for a ct scan which revealed an intracerebral hematoma in the left basal ganglion and left fronto-parietal region with midline shift and perilesional edema. Prothrombin time and activated partial thromboplastin time were prolonged with a normal platelet count. Enoxaparin was discontinued and six units of fresh frozen plasma were transfused, while mechanical ventilation was continued. The pt's coagulation status returned to normal within the next four days, and there was an improvement in neurological status. The hematoma had resolved and was not expanding so no evacuation was performed. The pt then developed ventilator-associated pneumonia and sepsis due to methicillin-resistant staphylococcus aureus on post-operative day 25. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2120144
« Last Edit: February 03, 2014, 02:50:27 AM by dennis100 » Logged
dennis100
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« Reply #4 on: November 05, 2013, 11:46:45 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/26/2010
Event Type  Injury   Patient Outcome  Required Intervention
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.
 
Event Description

Literature: ackermans l, duits a, temel y, et al. Long-term outcome of thalamic deep brain stimulation in two patients with tourette syndrome. J neurol neurosurg psychiatry. Oct 2010; 81 (10): 1068-1072. Summary: the authors conducted a follow-up study to report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described tourette patients. Reportable event: in patient 2, ((b)(6) male), the tic improvement at 8 months was slightly decreased at 6 years; compulsions had disappeared. This patient showed a decrease in verbal fluency and learning, a slight decrease in depression but overall psychopathology was still high at 6 years with an increase in anger and aggression together with difficulties in social adaptation. This patient reported a reduction in energy when the current intensity reached the level necessary for an optimal effect on tics; this patient did not adjust stimulation settings and preferred the feeling of drowsiness above his tics. This patient did experience a hardware-related complication consisting of traction of the lead in the neck. Multiple revisions of the wound and local injections were carried out with partial effect. This patient received seven replacements in 6 years due to his high-voltage stimulation. This patient experienced substantial improvement in sexual functioning at 8 months after surgery, but a slight decrease at the long-term follow-up except for sexual drive that increased to the maximum level. This patient experienced difficulty with his visual adaptation and vertigo, but neither of these complaints interfered with his daily life. Examination by an ophthalmologist did not reveal any disabilities. The adverse events experiences were not considered distressing at long term follow-up. See literature article with mfr report# 3007566237-2010-1064945.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943662
« Last Edit: February 03, 2014, 02:51:45 AM by dennis100 » Logged
dennis100
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« Reply #5 on: November 05, 2013, 11:48:54 PM »

Model Number NEU_INS_STIMULATOR
Device Problem Malposition of device
Event Date 01/01/2012
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
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. Continued concomitant medical products: neurostimulator model unknown serial# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown. (b)(6).
 
Event Description

Literature: ullman, michael, vinata vedam-mai, andrew s. Resnick, anthony t. Yachnis, nikolaus r. Mcfarland, stacy merritt, pamela z eilman, kelly d. Foote, and michael s. Okun. "deep brain stimulation response in pathologically confirmed cases of multiple system atrophy. " parkinsonism and related disorders 18 (2012): 86-88. Print. Summary: deep brain stimulation is a treatment for select cases of medication refractory movement disorders including parkinson's disease. Deep brain stimulation has not been recommended for treatment in multiple system atrophy patients. However, the paucity of literature documenting the effects of deep brain stimulation in multiple system atrophy patients and the revelation of a levodopa responsive subtype of multiple system atrophy suggests further investigation is necessary. This study summarizes the positive and negative effects of deep brain stimulation treatment in two pathologically confirmed multiple system atrophy patients from the (b)(6) deep brain stimulation-brain tissue network. Clinical diagnosis for the two patient cases did not match the neuropathological diagnosis. We noted that in both pathologically confirmed multiple system atrophy patients, death occurred as a result of myocardial infarction. Importantly, there was reported transient benefit in levodopa responsive features that indicate deep brain stimulation may be an option for select multiple system atrophy patients. Reported events: the patient underwent a dbs implantation on the left side in the globus pallidus internus (gpi) in (b)(6) 2004. The measured lead tip location for the left lead was -24. 6, -0. 5, -3. 6 (x,y,z), and was felt to be lateral to the optimal position. Following surgery the patient developed expressive aphasia which resolved over several weeks with therapy. The patient later developed a worsening gait. A brain mri revealed a lacunar infarct in the pallidum/internal capsule region. The left gpi_dbs and stroke reportedly improved his right hemibody parkinsonian symptoms. Although the dbs lead was sub-optimally placed, the infarct may have offered a beneficial lesion effect. The patient underwent right gpi-dbs implantation and repositioning of his left dbs lead in (b)(6) 2005. The measured lead tip location for the right lead was 22. 19, 4. 79, -2. 5 (x,y,z), and the measured lead tip location for the revised left lead was -20. 69, 7. 2, 11. 5 (x,y,z). The left lead was dorsally placed anterior and shallow to the optimal location, but the patient reported satisfactory improvement in his symptoms. Complications after the second dbs procedure included worsening of his speech intelligibility and pronounced sialorrhea. It was unclear from the dbs-btn notes whether this was direct result of surgery, or due to natural disease progression. The patient expired at the (b)(6) from a myocardial infarction. He showed no early cardiac problems, but pathologic evaluation revealed arterial/arteriolar sclerosis. 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=2484883

« Last Edit: February 03, 2014, 02:55:08 AM by dennis100 » Logged
dennis100
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« Reply #6 on: November 05, 2013, 11:49:35 PM »

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 03, 2014, 02:56:45 AM by dennis100 » Logged
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« Reply #7 on: November 05, 2013, 11:50:00 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 01/01/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt never experienced therapeutic effects on the "second side. " reprogramming had not been successful. The pt acquired a second opinion and was told the lead was "too deep. " three of the 4 electrodes were non-functional. Further info reported that immediately following left side implant, the pt experienced severe pain and headache. The headaches continued in the weeks prior to implantation of the neurostimulator. After the neurostimulator was implanted, three of the 4 terminals or cases did not seem to be operating, and it was thought that the pt's brain may have had some swelling which was expected to recede in a "few weeks. " after a scan, the pt was told the device "placement was perfect. " the pt's speech continued to deteriorate. Multiple reprogramming sessions had resulted in the same symptoms: slurred speech, little to no tremor relief, and occasionally facial pulling. A second physician informed the pt the device was "too deep in his thalamus and that it would never work properly" or that the device may be malfunctioning. The physician informed the pt that the first three cases could not be used because they were "through the area they needed to be in and because of that placement-could only have adverse affects. " the physician recommended a replacement of the neurostimulator. The pt left the appointment with his device turned off. The pt received a letter from his physician on (b)(6) 2011 stating that the lead placement was correct and that the pt was being released from care. Post-operative mris showed lead were directly parallel and 11. 5mm from the mid-line in the std. Impedances were within normal limits. Additional info has been requested but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2219647


« Last Edit: February 03, 2014, 02:57:15 AM by dennis100 » Logged
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« Reply #8 on: November 05, 2013, 11:50:31 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Type  Malfunction  
Event Description

It was reported that the patient was in a car accident and hit their head slightly. Since then their "thighs are constantly knotted into pain and their neck soft tissue was damaged and hurts all the time too. " it was reported that walking causes the patient severe pain. The patient visits their doctor "practically weekly" and she can get them moving, but the effect only lasts for about 4 hours. It was also reported that the patient's speech is slurred. 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2256356
« Last Edit: February 03, 2014, 02:57:57 AM by dennis100 » Logged
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« Reply #9 on: November 05, 2013, 11:51:48 PM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

The pt experienced a fairly severe shocking sensation when putting the time right on the clock and when checking impedances and therapy. Impedance measurements were good, reporting for problems. It was noted that he has fallen a number of times and probably hit his abdomen and not his head. He had an x-ray for pain over his ribs on the right side. The pt came in for an urgent care f/u. He had two swallow studies which showed he was aspirating. He was reprogrammed reducing the rate from 140 to 130 and was able to talk easier. He will have a f/u swallow study. The device was giving him therapy. He will be seen in two months or before hand if he has more problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913531
« Last Edit: February 03, 2014, 02:59:13 AM by dennis100 » Logged
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« Reply #10 on: November 06, 2013, 11:48:09 AM »

Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: vanderhorst vg, papavassiliou e, tarsy d, shih lc. Early brain abscess: a rare complication of deep brain stimulation. Mov disord. 2009; 24(9): 1396-1397. Summary/reportable event: postoperative ct scan of the brain showed normal postsurgical changes immediately post-op. On postoperative day 3, the pt developed confusion and fever and was readmitted. There was no evidence of scalp infection at the surgical site. The pt had fluctuating inattentiveness, incoherent speech without aphasia, and left leg hyperreflexia. White blood cell count (wbc) was 15,000. Cerebrospinal fluid (csf) contained 135 wbcs, 359 rbcs, protein 51 mg/dl, glucose 98 mg/dl. Serial brain ct scans with and without contrast over the next 4 days were normal. Empirical treatment included intravenous vancomycin and meropenem. Blood and csf cultures remained negative. Repeated csf studies 4 days after readmission showed 46 wbcs, 216 rbcs, protein 71 mg/dl, and glucose 71 mg/dl. Temperature normalized but alertness continued to fluctuate. No new neurological signs developed. Brain ct scan on postoperative day 8 showed a hypodensity surrounding the right dbs electrode without ring enhancement. Brain mri on postoperative day 10 demonstrated a ring enhancing lesion with surrounding vasogenic edema in the right frontal lobe. Following mri, right frontal craniotomy showed no evidence of scalp or subgaleal infection. Reddish-gray material was found subcortically, cultures of which grew enterobacter aerogenes. The right electrode was removed. Antibiotic treatment was changed to intravenous ertapenem and was continued for 6 weeks. Mental status normalized within 2 weeks. Repeat mri at 6 weeks showed near resolution of the infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562460
« Last Edit: February 03, 2014, 03:00:16 AM by dennis100 » Logged
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« Reply #11 on: November 06, 2013, 11:48:27 AM »

Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: tassorelli c, buscone s, sandrini g, et al. The role of rehabilitation in deep brian stimulation of the subthalamic nucleus for parkinson's disease: a pilot study. Parkinsonism relat disord. 2009; 15(9): 675-81. Summary: this article presents an observational study of 34 patients who underwent bilateral deep brain stimulation (dbs) implant in the subthalamic nucleus (stn) for the treatment of parkinson's disease. The patients were divided into three groups: acute (<1 months after implant), post-acute (1 month- 1 year after implant), and stabilized (>1 year after implant) based on the length of time between implant and referral to the neurorehabilitation unit. The patients were all treated with individualized physical, speech, and swallow therapy based on their initial assessment. Each pt showed significant improvement over baseline in at least one outcome measure. Reportable event: four patients in the post-acute group were referred to the neurorehabilitation unit due to motor fluctuations.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562524

« Last Edit: February 03, 2014, 03:01:36 AM by dennis100 » Logged
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« Reply #12 on: November 09, 2013, 02:19:35 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
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 pts of bilateral stn dbs with the electrode position estimated using fused magnetic resonance imaging. Reportable event: eighteen pts had experienced worsening of speech after bilateral stn dbs. See mfr report # 2182207200808567.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273927
« Last Edit: February 03, 2014, 03:01:58 AM by dennis100 » Logged
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« Reply #13 on: November 09, 2013, 05:40:57 AM »

Device Problem Explanted
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description

Journal ref: hooper ak, okun ms, foote kd, et al. Clinical cases where lesion therapy was chosen over deep brain stimulation. Stereotact funct neurosurg. 2008;86(3):147-152. In this paper we review the experience of movement disorders ctr from july 2002 to june 2007, and we identify cases in which a multidisciplinary team opted for lesion therapy over dbs. We will review the rationale for lesions and report the clinical course and outcomes in these individual pts. We will also discuss potential indications for lesion therapy. Reportable event: a man with a 29 yr history of et and a previous dbs lead presented for eval of worsening tremor. After 7 yrs, he presented with his speech affected and tremors that resulted in marked disability. He also experienced periodic panic attacks and depression. An mri of the brain revealed a left thalamic dbs lead with suboptimal placement. Surgery was scheduled to replace the lead; 2 weeks after replacement, he had left-side drainage from the head incision with infection. He had excellent tremor control, but the wound would not remain closed. It was then decided to remove the dbs sys and perform a thalamotomy. Mfr of the dbs devices was not stated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069604


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« Reply #14 on: November 09, 2013, 05:41:29 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: hariz mi, krack p, alesch f, et al. Multicentre foreign study thalamic stimulation for parkinsonian tremor: a 6 year follow-up. J neurol neurosurg psychiatry. 2008;79(6):694-699. To evaluate the results of ventral intermediate (vim) thalamic deep brain stimulation (dbs) in pts with tremor predominant parkinson's disease (pd) at 6 yrs post surgery. This was a prolonged follow-up study of 38 pts from eight centres who participated in a multicentre study, the 1 yr results of which have been published previously. This long term study was designed to evaluate the additional effect of thalamic dbs on tremor in pts taking their regular antiparkinsonian medication. Reportable event: adverse events reported by the treating centres as being related to stimulation included two cases of dysarthria. See mfg report 2182207200803776.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069574

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« Reply #15 on: November 09, 2013, 05:42:11 AM »

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

Journal reference: york mk, dulay m, macias a, et al. Cognitive declines following bilateral subthalamic nucleus deep brain stimulation for the treatment of parkinson's disease. J neurol neurosurg psychiatry. 2008;79(7):789-795. We investigated the cognitive, and psychiatric outcome 6 months after bilateral subthalamic nucleus deep brain stimulation (dbs) for the treatment of parkinson's disease (pd) using a disease control group. A total pts who underwent dbs were compared with medically treated pts with pd at baseline, and at 6 months for neuropsychological measures. Reportable event: one of the pts who underwent dbs converted to dementia over 6 months compared with none of the pd controls. This pt was a male who had been diagnosed with pd for 13 years. His wife reported confusion post-dbs that resolved after 2 wks and hallucinations that resolved after 8 wks. Six months following surgery, he experienced a marked improvement in his dyskinesias. While his "off" medication motor updrs score improved from 60 to 57 following surgery, his "on" score declined. He continued to experience freezing, and he had "drop attacks". Heis mmse score declined to 23/30. Memory, initiation, perseveration, fluency and both verbal and visual memory declined significantly. Mood remained consistent. See mfg report 218220705638.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159082

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« Reply #16 on: November 09, 2013, 05:42:42 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: york mk, dulay m, macias a, et al. Cognitive declines following bilateral subthalamic nucleus deep brain stimulation for the treatment of parkinson's disease. J neurol neurosurg psychiatry. 2008;79(7):789-795. We investigated the cognitive, and psychiatric outcome 6 months after bilateral subthalamic nucleus deep brain stimulation (dbs) for the treatment of parkinson's disease (pd) using a disease control group. A total pts who underwent dbs were compared with medically treated pts with pd at baseline, and at 6 months for neuropsychological measures. Reportable event: 26% of pts (6) who underwent dbs demonstrated a reliable decline in verbal fluency compared with only 4% of pd controls (p,0. 01). See mfg report 2182207200805638.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159083

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« Reply #17 on: November 09, 2013, 05:43:09 AM »


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: cilia et al. "brain networks underlining verbal fluency decline during stn-dbs in parkinson's disease: an ecd-spect study" parkinsonism & related disorders/2007/13/5/290-4. The study evaluated 20 patients with parkinson's disease preoperatively and 12 months after stn-dbs. Clinical and cognitive data were compared with 12 matched pd patients who had not undergone surgery. Reportable event: an unspecified number of patients experienced a significant decline in the category of verbal fluency. The decline was selective and the data does not indicate how many patients experienced the decline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078207
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« Reply #18 on: November 09, 2013, 05:57:08 AM »

Model Number 3387S
Device Problem No Known Device Problem
Event Date 09/14/2009
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening
Event Description

The pt experienced a hemorrhage after the lead was implanted. The physician realized that the hemorrhage occurred while implanting the second lead. The pt had no sense of feeling on the affected side; was unable to move her hand on command; and was unable to communicate. By two days after the event, the pt was stable and was moved out of the icu to a step down unit. As of 2009, the pt was still an inpatient on the rehab unit. The reporter was uncertain of her deficits post surgery, but understood that her issues centered around speech. The physician commented that the pt's dystonia had disappeared post lead implant comparable to a pallidotomy response. The physician had no plans at the present to implant a neurostimulator. See also mfr's report #60001532009-07179.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511270
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« Reply #19 on: November 09, 2013, 12:25:51 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description

During implant, the surgeon woke the pt up and told her to touch her nose with her right hand. The pt was unable to talk and tell the surgeon that she couldn't reach her nose; she couldn't move it. It was determined that the pt had a stroke on the operating table. The pt spent 4 days in the hospital following the stroke. The pt completed speech and physical therapy. The pt long term effects were that now she needed to write things down because she forgot and "cognitive things are hard". The pt was also depressed. The pt thought the surgery was going to change her life for the better, but it "ruined it".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1543921
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« Reply #20 on: November 09, 2013, 12:26:26 PM »

Device Problems Other (for use when an appropriate device code cannot be identified); No Known Device Problem
Event Date 06/20/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: okun ms, fernandez hh, wu ss, et al. Cognition and mood in parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the compare trial. Ann neurol. 2009;65(5):586-595. Summary: the study was a single-center, prospective, randomized, patient-and rater-blind, parallel-group trial that aimed to characterize and compare the effects of unilateral stn and unilateral gpi dbs on mood and cognitive function in patients with advanced pd. All patients were recruited, and 10 patients did not pass initial screening. A total were randomized to stn or gpi dbs. A total patients completed the study. Reportable event: some cases of difficulty with speech and language/increased speech were reported. Symptoms occurred in both implant locations (stn and gpi). Two cases were noted to be serious. No treatment or outcome was reported. A worsening of letter verbal fluency (hoehn and yahr stage of four or higher) was seen in an unspecified number of patient's with lead implanted in the stn verses pre-dbs. The deterioration was noted in optimal, dorsal, and especially off dbs conditions. The persistence of the deterioration in the off dbs state suggested a surgical rather than stimulation-induced effect. See literature article attached to mfr report # 2182207-2009-05291.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1432285
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« Reply #21 on: November 09, 2013, 12:26:55 PM »

Device Problem Device remains implanted
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative

 
Event Description

It was reported that the patient developed expressive aphasia following lead placement. The patient was hospitalized. The patient was reported as doing better and engaging in normal conversation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1424134
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« Reply #22 on: November 10, 2013, 03:56:57 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative

 
Event Description

Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease: five year follow-up. J neurol. 2009;256(2):225-233. Summary: this study assessed the long-term efficacy and safety of bilateral subthalamic nucleus (stn) stimulation in pts with advanced parkinson's disease (pd). A total consecutive pts with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that a pt experienced a left sided intracerebral hemorrhage during lead implantation surgery, with persistent aphasia. The pt subsequently developed dementia, and was lost to follow-up. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378208
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« Reply #23 on: November 10, 2013, 03:57:24 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Disability
Event Description

Literature: nebel a, reese r, deuschl g, mehdorn hm, volkmann j. Acquired stuttering after pallidal deep brain stimulation for dystonia. J neural transm. 2009;116(2):167-169. Summary: this case report supports the view of stuttering as a speech motor disorder of basal ganglia origin. Clinicians should be aware of acquired stuttering as a rare adverse effect of pallidal neurostimulation for treating segmental or generalized dystonia. It was reported that 24 months after surgery, the patient's speech was mildly imprecise with affected prosody by inadequate respiration while reading. Disfluency began 30 months after surgery with repetition of phonemes at word onset. At 3-year follow-up, stuttering was clearly present in terms of phoneme, word and syllable repetition and mild blocks while reading. During formal assessment by a speech therapist 38 months after implant, his spontaneous speech was nearly unintelligible with hard blocks repetition on phonemes, syllables and words. Stuttering was not immediately reversible by interrupting stimulation for periods of 30 min; nor did it improve during failure and revision of the right stimulation system due to a breakage of an extension cable. Attempts of lowering the stimulation amplitude or changing the contacts resulted in worsening of dystonic symptoms without improvement in speech. The patient accepted stuttering as a permanent adverse effect. The patient is receiving ongoing speech therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1366436
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« Reply #24 on: December 06, 2013, 01:23:41 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that after implantation of the stimulators, the patient¿s speech slowly began to worsen to the point where he was severely hypophonic and bradyphrenic at times when he attempted to speak. It was noted that over the prior few years, the patient had increasing stiffness and worsening posture and also had significant bradykinesia which increased when he walked. The patient underwent a revision of deep brain stimulation (dbs) leads a few years ago and at that time, it was noted that the leads dropped down the right side of his neck with the wires of both leads coming in contact with each other before they diverged into their respective generators in the bilateral chest.

 
Manufacturer Narrative
Product id 3389-40 lot# v005943, implanted: 2006 (b)(6); product type lead product id 3389-40, v005943, implanted: 2006 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2006 (b)(6); product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3459430
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« Reply #25 on: December 06, 2013, 01:29:26 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead. (b)(4).

 
Event Description
Amtage, f. , lambeck, j. , rutsch, s. , prokop, t. , pinsker, m. , rijntjes, m. Behind the screen: pseudobulbar symptoms after deep brain stimulation. In: nikkhah g, pinsker m, eds. Stereotactic and functional neurosurgery. Vol 117: springer vienna; 2013:43-46. Summary: thalamotomy was formerly used to treat different tremor syndromes. Nowadays deep brain stimulation has become an established technique to treat different movement disorders. The combination of these two stereotactic interventions is rare. We present a patient which a right-sided tremor syndrome with and underlying pathology of combined essential tremor and parkinsonian tremor was successfully treated initially with bilateral deep brain stimulation in the subthalamic nucleus resulted in hemidystonia pathological laughing and crying, dysarthria and dysphagia, all due to dislocation of the stimulation electrode contacting the internal capsule. After discontinuation of the high-frequency stimulation these side-effects disappeared, but were then reactivated by an lcd television in stand-by mode. In this report we discuss the pathophysiology of pseudobulbar symptoms and pathological laughing and crying in context of thalamotomy and dislocated dbs electrodes. Furthermore, we report on the occurrence that magnetic fields in the household have an impact on deep brain stimulation, even if they are in stand-by mode. Reported event: one (b)(6) female patient with a history of right-sided tremor syndrome which was treated by a left-sided thalamotomy had a deep brain stimulation (dbs) implantable neurostimulator (ins) implanted in the subthalamic nucleus (stn) for her emerging parkinson¿s disease (pd). Postoperatively, the patient complained of slight dysarthria and dystonia in the right leg when using stimulation. Several years later, the patient reportedly displayed right-sided hemidystonia and aggravation of the dysarthria, in combination with pseudobulbar signs such as dysphagia and pathological laughing and crying (plc) when the amplitude was increased. Seven years after implant, the patient admitted herself to the hospital and had a cranial ct scan taken. The ct scan revealed a dislocation of the left-sided electrode, leading to a stimulation of the medial parts of the internal capsule with the two uppermost contacts. The reporter stated that the right-sided electrode was placed in a pronounced dorsolateral position, stimulating the internal capsule at low amplitude at the second proximal contact. The reporter stated that testing of the remaining contacts for therapeutic effect reportedly showed no benefit to the pd symptoms. The ins was then switched off and the dysarthria, dysphagia, plc and right-sided hemidystonia disappeared completely; the patient was then discharged from the hospital. The patient denied a revision of the electrodes, as she was experiencing well-being under medication. The reporter stated that the patient¿s pseudobulbar symptoms were due to dislocation of both dbs stimulation leads into the internal capsule and the hemidystonic syndrome was provoked by the high-frequency stimulation of the cortico-spinal tract within the left internal capsule. The reporter suggested that there was a concomitant vulnerability of the circuit due to the left-sided thalamotomy. The reporter stated that the left-sided thalamotomy was not able to provoke plc by itself, only additional high-frequency stimulation of the internal capsule resulted in plc and other pseudobulbar symptoms. It was noted that the right-sided stimulation of the internal capsule did not produce a clinically-apparent dystonia, but rather spasticity of the left leg, since stimulation of only a small amplitude was applied. The reporter stated that switching off the right-sided stimulation yielded no benefit with respect to the plc, suggesting that bilateral pathology was therefore not mandatory to provoke plc. One month later, the patient reported a reappearance of the pseudobulbar symptoms during housework. The patient reportedly presented with right-sided hemidystonia and showed identical pseudobulbar symptoms as previously, including dysarthria, dysphagia and plc. The reporter stated that an assessment of the ins revealed that the high-frequency stimulation was again provoking the symptoms. The patient stated that stimulation had not been restarted by herself or a physician. The patient stated that the symptoms had suddenly reappeared while leaning over the television screen, which was in stand-by mode. The reporter stated that the magnetic field of the television interfered with the stimulator and switched it on again. It was noted that the magnetic switch of the stimulator had not been inactivated and the amplitude of the left-sided stimulation parameters had not been set to zero when stimulation had been turned off. It was noted that the amplitude of the right stimulation contact was still set to zero. The reporter stated that after deactivating the stimulator, the pseudobulbar signs promptly disappeared again. 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=3466513
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« Reply #26 on: December 06, 2013, 01:30:02 PM »

Model Number 7428
Event Date 10/17/2013
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported that the patient experienced a loss of therapeutic effect. It was noted that the patient had been in the hospital since (b)(6) 2013. It was further noted that the patient had a ¿parkinsonian episode on (b)(6) 2013, where the patient couldn¿t walk, swallow or eat and the patient had a drooping of the left side of her face and slurred speech. ¿ it was noted that the patient was taking her usual medications on that day, so they were unsure why the patient was having these symptoms. It was unclear what the status of the patient¿s stimulation was at that time. It was noted that this was a sudden change for the patient. It was noted that the patient had seen the physician within the month prior to the report and was doing fine. It was noted that they did tests and ruled out a stroke and all other testing that was done was negative. It was noted that ¿a short while after the patient arrived, the symptoms resolved and the patient returned to her usual baseline status. ¿ it was noted that the patient had not had any falls. It was not clear when the symptoms resolved. It was unknown if the stimulation had been turned off or if the patient¿s system was involved in any way.

 
Manufacturer Narrative
Concomitant medical products : product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473120
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« Reply #27 on: December 06, 2013, 01:30:39 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that after implantation of the stimulators, the patient¿s speech slowly began to worsen to the point where he was severely hypophonic and bradyphrenic at times when he attempted to speak. It was noted that over the prior few years, the patient had increasing stiffness and worsening posture and also had significant bradykinesia which increased when he walked. The patient underwent a revision of deep brain stimulation (dbs) leads a few years ago and at that time, it was noted that the leads dropped down the right side of his neck with the wires of both leads coming in contact with each other before they diverged into their respective generators in the bilateral chest. Additional information has been requested but was not available as of the date of this report.

 
Manufacturer Narrative
Concomitant medical products: product id: 7428, serial# (b)(4), implanted: (b)(6) 2006, product type: implantable neurostimulator. Product id: 3389-40, lot# v005943, implanted: (b)(6) 2006, product type: lead. Product id: 3389-40, lot# v005943, implanted: (b)(6) 2006, product type: lead. 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: 7436, serial# (b)(4), implanted: (b)(6) 2006, product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462913
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« Reply #28 on: December 07, 2013, 06:08:46 AM »

Model Number 37602
Event Date 09/13/2013
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 37642, serial # unknown, implanted: (b)(6) 2013, product type programmer, patient; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # v094755, implanted: (b)(6) 2008, product type lead; product id 3387s-40, lot # v050681, implanted: (b)(6) 2007, product type lead. (b)(4).

 
Event Description
It was reported that patient experienced loss of therapeutic effect post implant. It was added that the company representative had set the amplitude at 2/3v. It was reported that patient was having ¿internal shaking; no one could see it and felt nauseated. ¿ it was reported that four days after the day of this report the amplitude was changed back to old setting, 4. 1/4. 3v and patient felt fine for couple of hours. It was indicated that patient felt fatigue and her voice felt weak. It was noted that patient continued to have freezing and stiffness in the neck. It was added that there was no change in medication and anesthesia informed could be due to post-surgical. Additional information reported that the patient did not have access to adjust stimulation. Follow up from the health care provider reported right side impedances were high when they were checked on (b)(6) 2013. The patient was not getting effective stimulation. All impedances using contact zero were greater than 22,000 ohms. It was noted this was the patient¿s therapeutic contact. They attempted to reprogram using contact one. Programming was unsuccessful to the patient¿s satisfaction. The physician explored the stimulator site on (b)(6) 2013 and found a loose connection. Impedance check was normal and patient resumed therapeutic settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462365
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« Reply #29 on: December 07, 2013, 06:10:30 AM »

Model Number 37601
Event Type  Malfunction 
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v844032, implanted: (b)(6) 2011, product type lead; product id 3387s-40, lot # v844032, implanted: (b)(6) 2011, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension. (b)(4).

 
Event Description
It was reported that the patient had a loss of therapeutic effect. It was noted that the patient had a return of symptoms last night. It was noted that the programmer showed funny symbols and was not sure it was working. It was noted that the patient had symptoms of shaking, slowness and issues with their voice. It was noted that the device usually helped better than this. It was noted that yesterday the patient had an ekg yesterday for pain around the implant site that started 1. 5 weeks ago. It was noted that the ekg was to check the patient¿s chest pain around the site and they wanted to make sure it was note the patient¿s heart and they determined that the pain was due to scar tissue. It was noted that the patient described the screens on the patient programmer as an a and b and triangles with exclamation marks in them. It was noted that the patient navigated to the screen that showed the voltage of the im plantable neurostimulator (ins) was 2. 67 volts. It was noted that the patient had trouble seeing and describing and the patient crawled to get a magnifying glass. It was noted that the patient tried syncing with the device several times and finally determined the device was turned off. It was noted that the patient turned the device back on and felt nauseous. It was noted that the patient stated that when changing programs or turning the device on a nauseous feeling was normal for them. It was noted that after turning the stimulation on the patient felt better and could walk without falling. It was noted that the patient synced again and saw the stimulation was on and an elective-replacement-indicator (eri). It was noted that the patient had seen that message before but did not call. Additional information received reported that the stimulator got turned off somehow and the patient went the whole night without it and had a horrible night. It was noted that the patient did not realize it was off. It was noted that stimulation was turned back on and the symbol part was fixed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3470093
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