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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 08/31/2011
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld would not hold a charge, even when left plugged in overnight. The handheld would power on while plugged in; however once it was removed from the wall, the handheld would not come on. The handheld is normally stored at room temperature in the physician's office. The device has not yet been returned to the manufacturer for product analysis.

 
Event Description

The handheld and flashcard were returned to the manufacturer for analysis and analysis has been completed. An analysis was performed on the returned flashcard. No anomalies associated with flashcard software or databases were identified during the analysis. The flashcard and software performed according to functional specifications. An analysis was performed on the returned handheld. No anomalies associated with the handheld performance were noted during testing using a known good a/c adapter or the main battery with a full charge. The handheld performed according to functional specifications. It was noted during product analysis that the a/c adapter for the handheld device was not returned with the handheld; therefore proper function of the a/c adapter cannot be confirmed and a device issue cannot be completely ruled out. Attempts for the return of the a/c adapter have been unsuccessful to date.

 
Manufacturer Narrative

Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

While proper function of the handheld device was confirmed, a device charging issue cannot be ruled out as the a/c adapter for the handheld was not returned.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2263580
Report Number1644487-2011-02273
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/31/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number879565
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/27/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/12/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2010
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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