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U.S. Department of Health and Human Services

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

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IPG MFG SWITZERLAND KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Date 06/17/2015
Event Type  Injury  
Event Description

It was reported that 48 hours ago the patient was going through airport security and he passed through a medical detector. After passing through the patient sat near a security archway for about 15 minutes and then was required to pass through again. The patient was hospitalized, and had gone from a fully functional brain to now not able to hold a thought; he was unable to make a sentence and does not know where he is. The patient¿s wife described the patient¿s dementia as off the chart. The patient was incoherent and has been strapped down for safety. The patient¿s device was confirmed to be on, but the settings were unknown. Loss of therapy was reported. The patient¿s wife was trying to get a hold of the patient¿s implant doctor, but the doctor was currently away; she was going to try to get the patient transferred to his city. Follow up was performed but no additional information was available. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameKINETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CHINA 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 Key4900086
Report Number9614453-2015-01621
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2011
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Date Manufacturer Received06/19/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/20/2009
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: 07/08/2015 Patient Sequence Number: 1
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