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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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IPG MFG SWITZERLAND ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Injury  
Event Description

It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH  1131
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 Key4743368
Report Number9614453-2015-01031
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Date Manufacturer Received04/14/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/18/2013
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: 05/01/2015 Patient Sequence Number: 1
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