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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 12/01/2014
Event Type  Malfunction  
Event Description

It was reported that the patient's device has not been able to be checked because the physician's handheld has not been working. Further follow-up with the physician identified that an error executing run app message was observed. Troubleshooting was performed by performing a hard reset, but the message did not resolve. The flashcard was removed and reinserted and the device was powered off and then back on; however, the same message was received. Another hard reset was performed and the issue did not resolve. No additional relevant information has been received to date.

 
Event Description

The handheld and flashcard are expected to be returned, but have not been received to date.

 
Event Description

An analysis was performed on the returned programming handheld and flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the handheld, it was identified that the handheld was unable to load the vns version 8. 1 software. The cause for the anomaly is associated with a bent pin in the flashcard slot. Once the pin was straightened, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.

 
Event Description

The handheld, flashcard, and programming wand were received for analysis. Analysis of the programming wand was completed on 02/27/2015. The programming wand performed according to functional specifications. Analysis of the handheld and flashcard are underway, but have not been completed to date.

 
Manufacturer Narrative

New information received corrects the suspect device.

 
Search Alerts/Recalls

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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 Key4417857
Report Number1644487-2015-03610
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 12/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075847
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/20/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2005
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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