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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 37601
Event Type  Injury  
Event Description

It was reported the patient programmer showed an out of regulation (oor) message. The patient wanted to know if the oor message meant the implantable neurostimulator (ins) was no longer functioning because their symptoms had worsened considerably in recent weeks. The patient later reported the ins stopped working and they had an appointment scheduled for a replacement on (b)(6) 2014. A short in the patient¿s system had been found so the whole system was replaced. Following the replacement, the patient was receiving effective therapy.

 
Manufacturer Narrative

Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient. (b)(4).

 
Event Description

Additional information received reported that one electrode read 47 ohms when impedances were checked. The patient did not have any falls or trauma. The cause of the short was not determined. The entire system was replaced and the patient was fine.

 
Manufacturer Narrative

 
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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 120
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 Key4394483
Report Number3007566237-2015-00051
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/13/2015
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

Patient TREATMENT DATA
Date Received: 01/07/2015 Patient Sequence Number: 1
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