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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Event Description

It was reported that after a replacement the patient had hallucinations, line of sight blurring, and limb stiffness during the night. The patient went for programming in (b)(6) 2013, but the effect did not improve. The patient called into consult how to deal with it. The following day it was reported that the patient still had hallucinations and limb stiffness.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameKINETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
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 Key3662942
Report Number3007566237-2014-00632
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/17/2014
Was Device Evaluated By Manufacturer? No Answer Provided
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: 03/06/2014 Patient Sequence Number: 1
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