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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 10/31/2014
Event Type  Malfunction  
Event Description

It was reported that the physician¿s handheld device was not performing consistently and was unreliable. The handheld constantly required hard resets to temporarily return functionality. The suspect handheld device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The handheld device and software flashcard were returned to the manufacturer for analysis. It was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. Once connection was re-soldered, full product functionality was restored. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4280286
Report Number1644487-2014-03153
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/31/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073772
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/27/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2008
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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