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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number 250
Event Date 11/01/2010
Event Type  Malfunction  
Event Description

It was reported that the power cable on a physician's hp jornada handheld device was not making a good connection with the handheld; therefore, the handheld could not charge fully. A replacement handheld and power cable was sent to the physician and the hp jornada and power cable in question were returned to the manufacturer for analysis. During the analysis oft he handheld, it was identified that the connector to the handheld device was damaged and the ac adapter could no longer charge the main battery. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. 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.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1931687
Report Number1644487-2010-02640
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/01/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/22/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521397
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/04/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/01/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2003
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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