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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 04/11/2016
Event Type  Malfunction  
Event Description

It was reported that company representative's tablet is faulty. The tablet didn't turn on despite good charging of the device battery, other tablet with was connected with his own wand and usb white cable and the programming system worked fine. It was also reported that no switch on of the tablet is possible also when it is plugged into the wall outlet. The review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The return of the suspect tablet is expected but it has not been received to date.

 
Manufacturer Narrative

Date when the manufacturer's employee was aware about the event; corrected data: the previously submitted mdr inadvertently provided an incorrect initial aware date.

 
Event Description

The suspected tablet was returned to the manufacturer on 05/19/2016. An analysis was performed on the returned tablet and the reported allegation was not verified. No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications.

 
Event Description

It was noted during the analysis of the returned tablet that the main battery depleted; therefore the ac power adapter was suspected to be faulty. Attempts to the user, to return the ac power adapter, were unsuccessful. It was reported that suspected adapter was discarded.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5643645
Report Number1644487-2016-00984
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 04/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 11.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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