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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS INC PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 10/30/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's programming system was unable to interrogate a known working generator. Troubleshooting was performed which identified that the physician's programming system was found to not interrogate. The physician was provided a new programming system and the handheld and wand were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis an intermittent power connection associated with the serial cable was identified. The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector. The cause for the bent spring is unknown, but is most likely associated with mishandling of the device. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the wand was completed on (b)(4) 2014. The returned battery was depleted and was not the recommended type per labeling (battery type labeling recommends alkaline). After the battery was substituted, the programming wand 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
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4392435
Report Number1644487-2015-03544
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075851
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/24/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/25/2010
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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