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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 Date 03/21/2013
Event Type  Injury  
Event Description

It was reported there was periodic shocking sensations extending from the patient¿s left parietal location down to their jaw. This only happened when the right brain lead was on even more so when they used contacts two and three together. A short circuit in the wiring was noted. Impedance was low between contact 2 and 3. The device was replaced and the event was considered resolved without sequelae. Information on shocking and short circuit was originally reported in manufacturer report #¿s 3004209178-2012-12357 and 3004209178-2012-12352.

 
Manufacturer Narrative

Concomitant: product id 3387s-40, lot# va04pwk, implanted: 2012-(b)(6), product type lead. Product id 37602, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator. Product id 748251, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. Product id 3387s-40, lot# va048wb, implanted: 2012-(b)(6), product type lead. Product id 748295, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. (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 Key4638973
Report Number3004209178-2015-05564
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/27/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/27/2012
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: 03/27/2015 Patient Sequence Number: 1
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