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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report may have malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. (b)(4).

 
Event Description

It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information reported it was unknown what symptoms the patient had prior to the replacement surgery.

 
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Brand NameKINETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
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 Key4013492
Report Number3004209178-2014-15409
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/14/2009
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/18/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/23/2008
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: 08/15/2014 Patient Sequence Number: 1
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