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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 11/01/2011
Event Type  Malfunction  
Event Description

Additional information was received that product analysis was complete on the wand, handheld and flashcard. No visual or mechanical anomaly was identified with the wand. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications. The handheld was able to power on and off during testing with no observed anomalies. During the analysis it was identified that the ac adapter was no longer able to provide power to the handheld. A root cause for the ac adapter failure could not be identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Event Description

It was initially reported that the physician's handheld would not turn on. The handled was reported to be fully charged and plugged in, but would not turn on. The physician declined to perform troubleshooting. The wand, handheld and flashcard were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device failure was found, but did not cause or contribute to a death or serious injury.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2384812
Report Number1644487-2011-03183
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number874806
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/27/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2011
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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