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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
Device Problem Device Operates Differently Than Expected
Event Date 09/22/2015
Event Type  Malfunction  
Event Description

It was reported that a vns patient's device had an abnormal change in programming parameters / settings during 19 months after implant. It is not clear if the parameters were changed voluntary. It was reported that the patient experienced several adverse events during that period, that were said to be possibly or probably related to stimulation (abdominal cramps, larynx spasms, coughing and voice alteration with social impact). It was reported that these events may have led to the change in programming settings. The site indicates an off time of 180 minutes on the last recorder parameters with 0ma, on (b)(6) 2015. This was double-checked and confirmed by the physician. The normal mode stimulation parameters were as follows: output current, 0ma / frequency - 20hz / pulse width - 130usec / on time, sec / off time, 80min. No additional relevant information was received to date.

 
Event Description

Further information was received indicating that the reported 0ma (device disabled on (b)(6) 2015) was due to the adverse event: voice alteration. That event started on (b)(6) 2014 and the severity was mild. It was reported that the event was probably related to vns implant and probably related to vns stimulation. It was reported that the event was not a serious adverse event and it did not cause the subject to discontinue from the study. No further information was provided to date.

 
Event Description

Addition information was received indicating that the physician confirmed she programmed the generator to 0ma of output current and 180 min off times, following several patients adverse events already reported. The physician indicated that this was done intentionnally. It was reported that no device issue occurred.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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 Key5321978
Report Number1644487-2015-06834
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 11/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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