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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
Device Problems Connector; Break; Failure to Charge
Event Date 10/06/2009
Event Type  Malfunction  
Event Description

It was reported that the sites handheld was broken and that the connector piece in the handheld where the ac adapter is inserted had broken. The handheld would subsequently not charge as a result of the broken connector piece. The handheld, ac adapter, serial cable, db9 adapter, and (b) (4) software flashcard were returned to mfr for analysis. Analysis identified that the connector of the hand held device was damaged and the ac adapter could no longer charge the main battery. The cause of the damage ac adapter is unk, however, it is most likely associated with mishandling of the device. 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.

 
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 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1542373
Report Number1644487-2009-02461
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/07/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521426
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/14/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/07/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2002
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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