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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE HANDHELD

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CYBERONICS, INC. PROGRAMMING SOFTWARE HANDHELD Back to Search Results
Model Number MODEL 250
Event Date 01/03/2012
Event Type  Malfunction  
Event Description

Analysis was completed of the returned handheld. Analysis of the handheld revealed that during the analysis it was identified that handheld was unable to charge the main battery. The primary cause for the anomaly is associated with broken solder connections on the handheld main board. Additionally, it was identified that the returned ac adapter and cradle were unable to power and charge the returned handheld. The cause for the anomaly is associated with an incompatible aftermarket ac adapter. No further anomalies were identified. Moreover analysis of the flashcard indicated that 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.

 
Event Description

It was initially reported by a neurologist that his handheld computer could not be recharged due to unknown reason. There was no user mishandling reported to have contributed to the event. A new handheld was provided to the physician and the reported handheld was returned to the manufacturer for analysis.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DeviceHANDHELD
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2435359
Report Number1644487-2012-00255
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 830
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/02/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2007
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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