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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Type  Injury  
Event Description

The arrangement of the patient¿s stimulation was unusual in that he developed high impedance on all the leads to the left of them as well as a disappointing functional response with tremor in his right hand occurring as he wielded his tools in a pale beating job. The lead was re-implanted in the left posterior subthalamic area and connected to the implantable neurostimulator (ins). This occurred in (b)(6) 2013. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant product: product id neu_unknown_lead, serial # unknown, product type lead. (b)(4).

 
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Brand NameIMPLANTABLE 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 Key4882240
Report Number3007566237-2015-01817
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2015
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 Received06/09/2015
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: 07/01/2015 Patient Sequence Number: 1
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