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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number 250
Event Date 06/01/2008
Event Type  Malfunction  
Event Description

It was reported to mfr that their ac adapter cable for the hand held was frayed and requested that a new one be sent to the site. The non-working cable has been sent back to mfr and analysis is underway.

 
Manufacturer Narrative

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

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1081558
Report Number1644487-2008-01712
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/26/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/18/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/26/2008
Was Device Evaluated By Manufacturer? No
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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