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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
Device Problems Unable to Obtain Readings ; Low impedance; Malposition of device
Event Date 07/14/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 3389, serial# unknown, product type: lead. (b)(4).

 
Event Description

A health care provider (hcp) reported via a manufacturing representative that low impedances were measured on a lead during a follow up appointment. The patient was not getting much benefit from their system. Impedances were checked with a clinician programmer. Low impedances of 59 ohms were measured on electrode pair 0-1. "???" were measured on electrode pairs c-2 and 1-2. According to post operation ct scans, the lead appeared high so electrodes 0 and 1 were the best. The hcp assumed there was a short circuit between 0 and 1. No surgical intervention had occurred and it was unknown if intervention was planned. The issue was not resolved at the time of this report. No interventions 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

 
Event Description

Additional information reported there was "no change with regards to the patient" and that the patient's "problem was still there" as of (b)(6) 2015.

 
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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 1200
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 Key4973940
Report Number3007566237-2015-02199
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 07/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2015
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2015
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

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