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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 10/27/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's programming system was giving a "retry" message when trying to interrogate patient's devices. The wand battery was changed and the issue did not resolve. The wand was changed and interrogation was possible. It was later reported that the wand was working fine and that the issue was narrowed down to the usb connector. A new usb connector was used and there were no issues interrogating the generator. The usb was found to be kinked. The usb cable was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the returned usb adaptor was completed. The cause for the reported allegation is associated with two disconnected wire connections in the returned serial cable. Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 770
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 Key4277704
Report Number1644487-2014-03137
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/25/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2014
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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