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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 01/13/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld has a swollen battery. It was reported that the physician experienced issues with the display and removed the battery to reset, but that when the battery was removed, it was noticed to be swollen. A new programming tablet was provided to the physician and the handheld and flashcard were returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Additional information was received stating that the nurse¿s handheld device was stored in a drawer. It was reported that no mishandling had occurred.

 
Event Description

An analysis of the handheld verified that the main battery was swollen, but that the handheld performance was not affected. No performance anomalies associated with the main battery were identified during the analysis. The handheld performed according to functional specifications. No anomalies associated with flashcard software or databases 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 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3622544
Report Number1644487-2014-00383
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075226
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2010
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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