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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL KINETRA

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MEDTRONIC EUROPE SARL KINETRA Back to Search Results
Model Number 7428
Event Date 01/01/2009
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The pt was pulled by a speed boat while sitting on an inflatable chair. The ride was jarring. Afterward, the pt felt unconformable. Her left hand was going into spasm and her tongue was twisting, making it difficult for her to speak. The pt felt disoriented. Interrogation with the pt programmer revealed that the amplitude of the deep brain stimulator unit was set to 1. 6 and 1. 1 volts. Prior to the ride it was 0. 5 and 0. 6 volts. The upper limit of stimulation was set to 1. 0 volt. The pt's condition had returned to normal once the device amplitude was turned back down. The pt had pain in her neck where the wires were. The pt had not had problems with her deep brain stimulator after participating in water sports before.

 
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Brand NameKINETRA
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
tolochenaz
SWITZERLAND
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
tolochenaz
SWITZERLAND
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1521807
Report Number9614453-2009-07852
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/30/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/14/2010
Device MODEL Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Other
Date Manufacturer Received09/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/20/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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