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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 01/14/2015
Event Type  Malfunction  
Event Description

On (b)(46) 2015 the serial cable was returned for product analysis. On (b)(6) 2015 the handheld and flashcard were returned for product analysis. Product analysis is still underway and has not yet been completed.

 
Event Description

On 03/06/2015 product analysis was completed on the serial cable. No anomalies associated with the serial cable were noted during testing. The serial cable performed according to functional specifications. Product analysis was completed on the handheld on 03/18/2015. 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. 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.

 
Event Description

It was reported that the handheld¿s serial cable needed to be manipulated in order to work. A new serial cable was tried and the physician still had to ¿wiggle¿ the cable to get it to work, therefore it was believed the issue is with the handheld. The old serial cable worked fine with another programming system. Attempts have been made for product return but it has not been received to date.

 
Manufacturer Narrative

 
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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 Key4491144
Report Number1644487-2015-03770
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 01/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075838
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/19/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2012
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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