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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
Event Date 02/19/2015
Event Type  Malfunction  
Event Description

The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway. The programming wand was also returned to the manufacturer. Product analysis was completed for the programming wand on 06/05/2015. The battery was not returned; consequently, an analysis of the battery condition could not be performed. Continuity testing of the serial data cable and the battery cable passed. After the battery was installed, the programming wand performed according to functional specifications.

 
Event Description

It was reported that the physician's handheld had a constant orange and green power light and that every time the handheld is powered on the user is prompted to calibrate the screen. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

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

 
Event Description

Product analysis was completed for the handheld device on 07/01/2015. An analysis of the handheld was able to verify that the main battery was defective and unable to hold a charge. Once the battery was replaced, no further anomalies associated with the handheld performance were noted during testing. A swollen battery was confirmed, resulting in its inability to hold a charge for a minimum duration of 1-hour. Cause for the swollen battery is wear and age of battery. Product analysis was completed for the software flashcard on 07/01/2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
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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 Key4601451
Report Number1644487-2015-04151
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL
Device LOT Number1063832
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/29/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/25/2008
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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