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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 05/04/2009
Event Type  Malfunction  
Event Description

It was reported to manufacturer that the sites hp hand held ac adapter cord had broken and as a result, they were no longer able to charge the hand held. The site requested a new hand held be sent to replace that non-working device. It is unk how the ac adapter cord broke, but it was reported that "a black piece on the cord broke and fell off". Good faith attempts to obtain the non-working device for analysis have been made, but have been unsuccessful to date.

 
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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 Key1436502
Report Number1644487-2009-01046
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/05/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/20/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number530643
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2007
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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