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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KINETRA

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MEDTRONIC PUERTO RICO OPERATIONS CO. KINETRA Back to Search Results
Model Number 7428
Device Problems Loss of Power; Implant, reprogramming of
Event Type  Malfunction  
Event Description

It was reported that the pt experienced a loss of therapeutic effect and their jaw almost locked up and experienced speech and swallowing difficulties. Some of the pt's dystonia symptoms, specifically rigidity in their left hand returned. Add'l info rec'd reported that the pt's neurostimulator turned off and when power was restored, it was on an incorrect program. Reprogramming indicated that voltages had increased. Good results were observed with reprogramming. No injury was reported.

 
Manufacturer Narrative

(b) (4).

 
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Brand NameKINETRA
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road #31 km 24 hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO
road #31 km 24 hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1478820
Report Number3004209178-2009-04004
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/13/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/28/2009
Device MODEL Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/13/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2008
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: 06/09/2009 Patient Sequence Number: 1
Treatment
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXPLANTED:
EXTENSION: MODEL 7482A, LOT# NHU178116V
EXTENSION: MODEL 7482, LOT# NHU174685V
PROGRAMMER: MODEL 7436, LOT# NFU020176P
IMPLANTED:
LEAD: MODEL 3387S, LOT# V107988
LEAD: MODEL 3387S, LOT# V100746
IMPLANTED:
EXPLANTED:
EXPLANTED:
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