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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 MODEL 250
Event Date 10/29/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld was failing to interrogate a patient's generator. A different programming system was used which successfully interrogated the patient's generator. It was reported that the handheld that was unable to interrogate the generator was freezing at the interrogation in progress screen. No troubleshooting was able to be performed at that time. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

On 01/08/2015 the handheld and flashcard were received for product analysis. On 01/20/2015 product analysis was completed on a returned handheld. During the analysis it was identified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Once a known battery cover was installed, the handheld performed according to functional specifications. This event was reported on mfr. Report # 1644487-2015-03668. Product analysis was also completed on the flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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 Key4281145
Report Number1644487-2014-03160
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073771
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2012
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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