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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 Type  Injury  
Event Description

It was reported the essential tremor patient experienced reduced therapy post-operatively with ¿less than 50% therapy relief. ¿ the patient also experienced a shocking sensation down their arm and spasms. These issues were reported to have occurred after the patient had a large fall. Prior to the fall it was noted he patient ¿had good tremor suppression. ¿ a revision procedure was performed whereby the patient¿s scalp was opened and it was observed the lead was ¿visibly fractured. ¿ the lead was ¿fractured slightly distal from where bone cement secured the lead. ¿ it was noted the ¿damage was detected capping the lead. ¿ impedance testing was performed with an external neurostimulator (ens) at that time and found that contact 0 was ¿open. ¿ as a result, the bone cement present with the lead was drilled and the lead was removed and replaced with a new lead. The patient was to have their therapy switched on 17 days aft er initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Concomitant medical products: product id 3387-28, lot# unknown, implanted: (b)(6) 2002, explanted: (b)(6) 2015, 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 Key4841423
Report Number3007566237-2015-01640
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/26/2015
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: 06/12/2015 Patient Sequence Number: 1
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