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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 patient had intermittent shorts, saw an elective replacement indicator (eri), and had the problem corrected even though the battery had a significant bounce back. No symptoms or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant products: product id neu_unknown_ext, serial # unknown, product type extension; product id neu_ unknown_lead, lot # unknown, product type lead; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext, product type: extension. Product id neu _unknown_lead, product type: lead. Product id neu_unknown_prog, product type: programmer, physician.

 
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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 Key4300393
Report Number3007566237-2014-03522
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2014
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? No
Date Manufacturer Received01/15/2015
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: 12/05/2014 Patient Sequence Number: 1
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