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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
Device Problem High impedance
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 748251, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 64002, product type: adapter. Product id 3550-29, product type: accessory. (b)(4). Device evaluation: analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 23. 2 cm from the distal end. ¿ analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 47. 0 cm from the distal end. ¿ analysis of extensions (b)(4) and (b)(4) and the pocket adapter found no anomalies.

 
Event Description

The patient's physician reported the patient "felt electrifying pain near the implantable neurostimulator (ins) and toward poor in the right side. " it was noted this had occurred following an ins replacement with an ins and pocket adapter, though initially following the replacement "everything was ok. " the patient reported they felt increasing electrical pain in the area of the ins with the pain radiating into their arm following the replacement. Initial impedance testing performed after the implant of the ins and adapter found "normal" impedances. Impedance testing performed at the time of report found the impedances were "too high" to be measured. The patient's physician performed troubleshooting through a revision procedure as a result. First, the physician changed the patient's pocket adapter, with "no improvement of the impedances. " the physician then changed the patient's extensions ((b)(4) and (b)(4)), "but with the new extensions the impedances were not measureable, so the physician changed the new extensions ((b)(4) and (b)(4)) again with two new extensions. " the impedances for contacts 0 and 8 reportedly remained not measurable at that time. It was reported the second pair of replacement extensions remained implanted at the time of report and the patient was "well" and "got an effective therapy" from their device. The physician was to be followed-up with a week after initial report. A supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Conclusion codes: please note that conclusion code has been replaced at this time. We did not make design enhancements in this case: recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code because it is the closest code available with respect to this event.

 
Manufacturer Narrative

 
Event Description

Additional information reported the patient "felt electrifying pain and the impedances were not measureable" with their initial extensions. A surgical revision was performed to troubleshoot the situation and the extensions were replaced. Impedance testing performed after the replacement of the patient's initial extensions "showed high impedances. " the replacement extensions were then disconnected, cleaned, and reconnected, but additional impedance testing "showed no measurable impedances. " these replacement extensions were then replaced at that time. The patient's system "showed normal impedances: with the second set of replacement extensions.

 
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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 Key5004520
Report Number3007566237-2015-02280
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2015
Was Device Evaluated By Manufacturer? Yes
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: 08/14/2015 Patient Sequence Number: 1
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