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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS KINETRA Back to Search Results
Model Number 7428
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 10/01/2008
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported the patient was experiencing nervousness and shaking for the last 2 to 3 days. The left hand and leg seemed to be the most affected. The patient had experienced a fall approximately ten days prior. Since the fall, walking had gotten substantially worse. The patient had gone to the er (date unknown) and was given benadryl, which seemed to calm her nerves. The patient was at home at the time of the report. Additional information has been requested, but was not available on the date of this report.

 
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Brand NameKINETRA
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
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 Key1277784
Report Number3004209178-2008-07661
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/14/2008
Device MODEL Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/27/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/25/2007
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: 11/21/2008 Patient Sequence Number: 1
Treatment
EXPLANTED:
EXPLANTED:
LEAD: MODEL 3387
LEAD: MODEL 3387
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482
EXPLANTED:
EXTENSION: MODEL 7482
PROGRAMMER: MODEL 7436
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