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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  
Event Description

It was reported that the patient had three implantable neurostimulators (ins), one of which was dead. The reporter noted that ¿the batteries implanted a year ago were dead. ¿ the reporter was unable to confirm if the two active inss were on or off. The patient had a loss of efficacy unrelated to stimulation therapy; he was experiencing light headedness, dizziness, and hypoxia. These symptoms were believed to be device related and the patient was admitted to the hospital the day prior to the report. The reporter tried to reach out to both physicians involved with the patient, but both were ¿clueless. ¿ the patient outcome was not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing reports #3004209178-2015-00006 and 3004209178-2015-00015 for both of the other inss.

 
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v813689, implanted: (b)(6) 2012, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, 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 Key4377442
Report Number3004209178-2015-00019
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/10/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/21/2013
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: 01/02/2015 Patient Sequence Number: 1
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