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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 06/29/2011
Event Type  Malfunction  
Event Description

It was initially reported that the physician was having issues communicating with a pt's generator and was receiving the error message "there is an error establishing communication with the device, try repositioning the wand". They repositioned the wand, replaced the 9v battery and checked all connections but was still unsuccessful with communicating with the generator. The pt was taken to a different room and was able to be interrogated and it was confirmed that the pt was not at end of service. However, the error message was received again when diagnostics were attempted. The office was eventually able to perform a final interrogation to confirm the pt was at intended settings. Additional info came in indicating that the handheld was not charging. The indicator light would be red if she held the cord but would go off when the cord was released. A new handheld was sent to the site and they were able to use it successfully with their current wand. The handheld and flashcard were returned to the mfr for eval. No anomalies associated with the handheld serial cable were noted during testing. During the analysis, it was identified that the ac adaptor was defective and unable to supply power to the handheld. No further anomalies were identified using a known good ac adapter. 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 Key2199164
Report Number1644487-2011-01711
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/29/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number839583
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/07/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/29/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2005
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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