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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 company representative's handheld was not holding a charge after charging. Troubleshooting was performed which identified that the handheld and charging cable had an incomplete connection and that when the connection was reconnected the handheld charged and held the charge appropriately. It was reported that the handheld and cable are touchy at times but the handheld is always able to be connected and charge properly. The company representative was provided a new cable. No additional relevant information has been received to date.

 
Event Description

The handheld computer programmer, software and serial adapter cable were returned to the manufacturer for product analysis on 6/11/2015. The ac power adapter was not returned.

 
Manufacturer Narrative

Report source, corrected data: the initial report inadvertently indicated a health professional was also a report source. The only report source was the company representative.

 
Event Description

Additional information received indicated that the original suspect serial adapter cable was discarded and that the returned serial adapter cable is a different cable. During the analysis of the handheld programmer it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged solder connections between the handheld sync connector and the main pcb. 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 cable receptacle. No other anomalies were identified. No anomalies associated with the returned serial cable were identified during the analysis. No anomalies were noted with the software flash card. The software performed accordingly 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 Key4432294
Report Number1644487-2015-03666
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMODEL 250
Device LOT Number1073773
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/07/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2010
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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