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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
Device Problem Premature Discharge of Battery
Event Date 10/09/2015
Event Type  Malfunction  
Event Description

It was reported that the handheld's battery would not hold a charge. The handheld has been received for analysis, which is underway but has not been completed to-date. No additional information has been received to-date.

 
Event Description

Analysis was performed on the returned handheld. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the ac adapter was damaged and unable to power the handheld. The cause of the damage was associated with mishandling of the device. No further anomalies were identified. An analysis was performed on the returned flashcard and no anomalies associated with the flashcard software or databases were identified during the analysis. The flashcard and software performed according to specifications.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5202415
Report Number1644487-2015-06323
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 10/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number536290
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/14/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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