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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 11/21/2014
Event Type  Malfunction  
Event Description

Analysis of the returned handheld device and flashcard were completed where no issues were found with the flashcard or associated software. During analysis of the handheld it was observed that the battery latch was functioning properly however the handheld device would still not power on. The cause for the inability to power on was due to a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld device from powering on (this condition can also cause the handheld device to power off intermittently). Additionally it was identified that the main battery was unable to fully charge and power the handheld device for over 30 minutes. The cause for the anomaly is associated with a defective main battery.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the physician¿s handheld device was not functioning. The battery latch would not close and therefore the device could not be used. The wand was confirmed to not be causing or contributing to the issues. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

 
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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 Key4347788
Report Number1644487-2014-03421
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 11/21/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1077284
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2007
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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