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U.S. Department of Health and Human Services

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

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

A health care provider (hcp) reported via a manufacturing representative that impedances were measured to be low for all electrodes. A single impedance values for all monopolar configurations and a single impedance value for all bipolar configurations led the hcp to the conclusion that the electrodes were short circuited. The hcp claimed the stimloc clamp squeezed the clamp too much, when the hcp tried to withdraw the stylet from the lead, the hcp had over tightened the screw of the ¿white plastic part¿ that holds the lead on the microdrive. When the hcp pulled the stylet, they broke the white plastic electrode cover where the stylet was fixed, stressing and damaging the lead just below the connector. All of the implanted components were tested from the implantable neurostimulator (ins) to the lead to identify the location of the short circuit. The lead was identified as the damaged part. The lead was not able to be replaced during the initial surgery so a revision was scheduled five days later using the previous planning and ct scans. After the lead replacement, the issue was resolved.

 
Manufacturer Narrative

Concomitant product: product id 3389s-40, lot # va0tf9y, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id neu_unknown, serial # unknown, product type unknown. (b)(4).

 
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Brand NameEXTERNAL NEUROSTIMULATOR, UNKNOWN
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 Key4973843
Report Number3007566237-2015-02198
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/14/2015
1 Device Was Involved in the Event
1 Patient Was 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_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_STIMULATOR
Was Device Available For Evaluation? No
Date Manufacturer Received07/14/2015
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: 08/05/2015 Patient Sequence Number: 1
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