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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 05/16/2008
Event Type  Malfunction  
Event Description

Reporter indicated a vns patient was unable to be interrogated. The pt's vns is implanted subpectorally. The pt has had a history of being difficult to interrogate due to the generator's positon but has been successfully interrogated in the past. Attempts for further info from the reporter have been unsuccessful to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contributed to a death or serious injury.

 
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Brand NamePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1059923
Report Number1644487-2008-01362
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/16/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/16/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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