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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 Date 08/02/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The consumer via a manufacturer representative reported that an implantable neurostimulator (ins) was implanted in the patient on (b)(6) 2014 due to parkinson¿s disease. On (b)(6) 2015, the patient had difficulty walking and adjusted the parameters with the patient programmer, but had no improvement. The patient¿s family requested a solution for the symptom. No troubleshooting was done to provide insight to the issue and the cause of the event was not determined.

 
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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 Key5035261
Report Number3004209178-2015-16841
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation
Report Date 08/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/08/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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