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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, the patient had a lead revision approximately four weeks prior to this report. The patient¿s healthcare professional (hcp) wanted the implant left off for four weeks after implant, but a nurse had turned the implantable neurostimulator (ins) on. The patient had complications from the revision surgery and they had difficulty with speech and resting tremor at the time of this report. The inss were turned on prematurely to help control tremors. The patient was in a rehabilitation center for recovery and their prognosis was day to day. The manufacturing representative stated the patient¿s issues were not so much from the ins, but from complications from the surgery. 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. Refer to manufacturer report #3004209178-2015-05486.

 
Manufacturer Narrative

Product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va0b8hm, implanted: 2013 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# va0b8hm, implanted: 2013 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# va0b8hm, implanted: 2013 (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 Key4636007
Report Number3004209178-2015-05488
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/14/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/19/2013
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: 03/26/2015 Patient Sequence Number: 1
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