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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 12/10/2014
Event Type  Malfunction  
Event Description

The handheld and related software were received by the manufacturer. An analysis was performed on the returned handheld, and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the 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. No anomalies were found with the software/flashcard.

 
Event Description

It was reported that the physician¿s programming handheld would not stay on when unplugged from the power source. The physician¿s office reported leaving the handheld plugged into the power source for weeks, but it dies when removed from the charger. Product return is expected, but the suspect device has not been received to date.

 
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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 Key4365021
Report Number1644487-2014-03463
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 12/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2008
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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