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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 01/05/2015
Event Type  Malfunction  
Event Description

It was reported that the serial cable connection to the handheld was loose. It was verified that the issue was with the handheld as the serial cable functioned fine with another handheld. Another serial cable was tried with the handheld and it was also found to be loose in the handheld. The handheld and flashcard were returned for product analysis on 01/27/2015. Product analysis is still underway and has not yet been completed.

 
Event Description

Product analysis was completed on the flashcard on 02/12/2015. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Product analysis was completed on the handheld on 02/12/2015. Non-responsiveness from the handheld was found to be due to a damaged connector receptacle where the serial data cable normally attaches; receptacle became partially separated from the main pcb with some broken connector pins; most likely associated with wear or excessive cable manipulation. During the analysis on the handheld it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with bad solder connections between the sync connector and the main pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the 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 sync connector. No other anomalies were identified.

 
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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 Key4460625
Report Number1644487-2015-03702
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 01/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073772
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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