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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 Problem Replace
Event Date 02/03/2009
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported the stimulator was replaced due to pt reports of change in speech, contraction of right arm and hand, tingling and drawing of the right side of the face and mouth when head turned toward right. When the system is on, a shocking sensation is felt at first then it levels off the symptoms.

 
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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 Key1325826
Report Number3004209178-2009-01273
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/28/2009
Device MODEL Number7428
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/11/2009
Is The Reporter A Health Professional? Yes
Device Agemo
Event Location Other
Date Manufacturer Received01/26/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/13/2008
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: 02/24/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
PROGRAMMER MODEL 7436 LOT# NFU007145P
EXPLANTED:
IMPLANTED:
IMPLANTED:
EXPLANTED:
EXPLANTED:
LEAD MODEL 3387 LOT# J0427852V
IMPLANTED:
EXPLANTED:
EXTENSION MODEL 7482 LOT# NHU169929V
IMPLANTED:
EXTENSION MODEL 7482 LOT# NHU163739V
IMPLANTED:
LEAD MODEL 3387 LOT # J0428292V
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