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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 Date 02/25/2015
Event Type  Injury  
Event Description

It was reported the parkinson¿s disease patient experienced ¿less than 50% therapy relief¿ in their ¿left hemibody¿ at the time of report. ¿immediately after implantation¿ impedance testing was performed and ¿showed a short on two contacts. ¿ the impedance testing records indicated bipolar electrode pair 1 and 2 had a low impedance value of 32 ohms (also reported as 52 ohms). It was noted that no impedance measurements had been taken during implant. Reprogramming the patient was reportedly ¿difficult,¿ but the patient ¿was receiving therapy¿ as of 19 days after initial report. A date to revise the patient¿s system was not yet planned; but a revision was expected as the patient¿s ¿neurologist was convinced [the patient] would be better with an intact system. ¿ additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Concomitant: product id 3708660, implanted: 2015-(b)(6), product type extension. Product id 3389-40, lot# unknown, implanted: 2015-(b)(6), product type lead. (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 Key4628331
Report Number9614453-2015-00547
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Date Manufacturer Received03/04/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/05/2015
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: 03/24/2015 Patient Sequence Number: 1
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