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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2015
Event Type  Malfunction  
Event Description

It was reported that on (b)(6) 2015, the patient became inarticulate and had leg muscle stiffness. Reprogramming was done in (b)(6) 2015 and the patient¿s healthcare professional (hcp) turned stimulation up to 2. 5v from 2. 0v, but there was no symptom improvement. The cause of the event was not determined. The patient wanted to know if there are any better solutions. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information received from a manufacturing representative reported that no further diagnostics or testing was done and no additional actions or interventions had been taken.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
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 Key4949605
Report Number3007566237-2015-02126
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2015
Was Device Evaluated By Manufacturer? No Answer Provided
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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