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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 3389S-40
Event Date 07/16/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: neu_stylet_acc, product type: accessory. Product id: 3389s-40, lot# va0xc9r, implanted: (b)(6) 2015, product type: lead. (b)(4). Analysis of the lead (lot# va0uvrw) found a procedural non-conformance. The lead body outer insulation was damaged at the depth stop site.

 
Event Description

The manufacturer representative (rep) reported that there was a short circuit on combinations 0 and 3, which was discovered intra-operatively. The impedance between 0 and 3 was 12 ohms. The lead was replaced after noting the short. The rep indicated that the health care professional (hcp) on the second lead noted he attached the depth stop. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
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 Key4987821
Report Number6000153-2015-00159
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation
Report Date 07/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2018
Device MODEL Number3389S-40
Device Catalogue Number3389S-40
Device LOT NumberVA0UVRW
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2015
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/16/2015
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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