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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 37601
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# v003141, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v001355, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension. (b)(4).

 
Event Description

It was reported that there was a loss of therapeutic effect, the patient¿s left hand had begun to shake and they had found a wire was broken. It was unknown when it had broken but the shaking had begun in (b)(6) of 2010. The patient had put up with it and had said it had not bothered him. The patient¿s hand would turn in and he would keep it closed. The lead and implantable neurostimulator (ins) were replaced and the issue was resolved. The patient had it adjusted and then had never had to go back again.

 
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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 Key4333043
Report Number3004209178-2014-24002
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 11/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/14/2011
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Date Manufacturer Received11/24/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2009
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: 12/16/2014 Patient Sequence Number: 1
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