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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 03/03/2015
Event Type  Malfunction  
Event Description

It was reported that the company representative's programming system was unable to program a patient's device off. Troubleshooting was performed which identified that the programming wand was not functioning. The company representative was provided a new programming wand and the nonfunctional wand was received for analysis. It was later reported that the issue remained with the new programming wand. The company representative indicated that the "unable to open port" error message was still being received indicating a possible problem with the usb cable that connects the wand and tablet. The company representative was provided a new usb cable. The nonfunctional usb cable is expected to be returned for analysis, but has not been received to date. Analysis of the programming wand was completed on 03/26/2015. No visual or mechanical anomaly was identified. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications.

 
Event Description

Information was received from a company representative on (b)(6) 2015 that the tablet serial cable is lost and will not be returning to the manufacturer for analysis.

 
Manufacturer Narrative

 
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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 Key4638077
Report Number1644487-2015-04269
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/19/2014
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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