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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 04/01/2010
Event Type  Malfunction  
Event Description

It was reported that the site's charging cradle was broken. Troubleshooting was performed where the ac adapter cable was moved from the back of the cradle, and plugged into the flying lead on the serial cable. This configuration was plugged directly into the hand held rather than using the charging cradle. It was observed that touching or moving the connection caused intermittent charging. The site was sent a new cable to replace the non-working cable. The non-working cable has been retrieved, is en route to mfr for analysis.

 
Manufacturer Narrative

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

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1706682
Report Number1644487-2010-01182
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/23/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/23/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
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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