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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 01/26/2015
Event Type  Malfunction  
Event Description

It was reported that the physician was having difficulty turning on the programming handheld. The screen lock button, the battery latch, and the wall outlet were all checked, which did not resolve the issue. A soft reset was performed but the handheld only flashed the red light on the power button and nothing appeared on the screen. A hard reset only resulted in a ¿¿battery critically low¿ message appearing on the screen. The office had another programming handheld and when they tried to plug that one into the power cable of the first programming handheld, there was an inability to charge that one as well. It was therefore believed that the issue may be with the power cable and a new power cable was sent to the physician, but this did not resolve the issue with the programming handheld not turning on. It was reported that the programming handheld would be returned for product analysis but it has not been received to date.

 
Event Description

On (b)(6) 2015 it was reported that the handheld may have gotten ¿zapped¿.

 
Event Description

The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2015. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2015. No anomalies associated with flashcard software or databases 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 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 Key4524519
Report Number1644487-2015-03880
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2012
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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