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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37602
Event Type  Injury  
Event Description

It was reported that there was a short in a wire and the patient got zapped when they turned their head. This first occurred in (b)(6) 2014, but also occurred in the fall, and recently. The implantable neurostimulator (ins) had showed low battery over a week prior to this report due to the short. A replacement surgery was scheduled for monday. No outcome was 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

Product id 37602, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# v192123, implanted: 2009 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v335517, implanted: 2010 (b)(6); product type lead. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
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 Key4752036
Report Number3004209178-2015-08540
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/13/2012
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: 05/06/2015 Patient Sequence Number: 1
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