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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 01/10/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld would not power on after being charged. It was also reported that the handheld wouldn't connect. The physician was provided with a new programming tablet. The handheld is expected to be returned, but has not been received to date.

 
Event Description

The handheld, flashcard and wand were received for analysis. Analysis of the wand was completed on (b)(4) 2014. ¿as received¿ the programming wand did not communicate, which analysis on the pa lab test bench determined was caused by a depleted battery. After the battery was substituted with a known good bench battery, the programming wand passed all communication testing at various orientations. Passing electrical tests demonstrated that current consumption rates were within specification, thereby eliminating any possibility of a condition where a battery might be prematurely depleted by the wand circuitry. Continuity testing of the serial data cable and the battery cable passed. No mechanical or visual anomaly was identified. After the battery was substituted, the programming wand performed according to functional specifications as evaluated through 38-0004-3600. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the handheld was completed on (b)(4) 2014. 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 Key3611359
Report Number1644487-2014-00368
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2014
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? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/28/2014
Was Device Evaluated By Manufacturer? Yes
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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