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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

Additional information received reported that impedance testing was done and impedances were measured to be around 200 ohms. The patient suffered from balance problems related to parkinson's and they fell frequently. The patient outcome was good and they were being treated with antibiotics. When the infection resolves the patient would be implanted again.

 
Event Description

It was reported the implantable neurostimulator (ins) prematurely depleted. End of service (eos) was displayed 10 months after implant. After testing impedances, a short circuit was found. The ins pocket was infected, inflamed, filled with fluid and very swollen. A culture of the ins pocket was taken and antibiotic treatment was necessary. The patient had less than 50 percent therapy relief. The ins was explanted. The patient status at the time of this report was alive with no injury. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

 
Manufacturer Narrative

(b)(4). Analysis of the implantable neurostimulator (ins) found no significant anomaly. The ins battery was at normal end of life and telemetry and output were okay. The longevity of the ins was calculated with the parameters from the initial review, with 1000o impedances: elective replacement indicator (eri) = 41. 28 months and end of service (eos) = 44. 28 months. Testing of the ins did not reveal any shorts. The insulation coating on the ins was delaminated. The ins also had the case electrode programmed.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key4484708
Report Number9614453-2015-00030
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2013
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: 02/04/2015 Patient Sequence Number: 1
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