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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Date 02/28/2011
Event Type  Death  
Event Description

Hwynn, n. , hass, c. J. , zeilman, p. Romrell, j. Dai, y. , wu,s. Foote,k. , subramony, s. H. , oyama, g. ,velez-lago,f. , fernandez,h. , resnick,a. , malaty,i. , okun,m. Steady or not following thalamic deep brain stimulation for essential tremor. J neurol. 2011;258(9):1643-1648. Doi 10. 1007/s00415-011-5986-0 summary: deep brain stimulation (dbs) has become an important option for medication-refractory essential tremor (et), but may contribute to worsened gait and falling. This study evaluates impaired gait in a cohort of patients treated with dbs with a retrospective review of et patients before and after dbs implantation. Factors examined included: age, duration of symptoms, pre-morbid gait difficulties/falls, fahn-tolosa-marin tremorrating scale (trs) scores at baseline, 6 months post-unilateral dbs implantation, and 6 or 12 months post-bilateral implantation. All implantations targeted the nucleus ventralis intermediate (vim). Thirty-eight patients (25 males, 13 females) were included. Twenty-five patients (65. 8%) underwent unilateral dbs implantation and 13 (34. 2%) bilateral. The mean age at surgery was 67. 1 years ± 11. 4 (range 34¿81). The mean disease duration was 31 years ± 18. 3 (range 6¿67). Fifty-eight percent of patients had worsened gait postoperatively. Seventy percent of patients with unilateral vim dbs experienced gait worsening while 55% of bilateral dbs patients experienced gait worsening. Patients with worsened gait post-dbs had higher baseline preoperative trs scores than those without worsened gait (43. 1 points ± 8. 4 vs. 33. 1 points ± 10. 1, p = 0. 002) (odds ratio 2. 5, p = 0. 02). Gait/balance may worsen following dbs for medication refractory et. Higher baseline trs score mayfactor into these issues, although a l arger prospective study will be required with a control population. The larger percentage of difficulties observed in unilateral versus bilateral cases likely reflected the bias to not proceed to second-sided surgery if gait/balance problems were encountered. Reported events: 1. 1 patient had postoperative dbs-unrelated death before clinic follow-up 2. 2 patients had postoperative infection resulting in leads surgically removed within 6 months post-dbs 3. 1 patient had ischemic stroke. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative

The actual event dates were not provided. This date is based on the date of publication of the article. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Product id: 3387, lot# unknown, product type: lead. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: 3387, lot# unknown, product type: lead. (b)(4).

 
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Brand NameUNKNOWN IMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key3229671
Report Number3007566237-2013-02357
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/13/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2013 Patient Sequence Number: 1
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