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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/18/2012
Event Type  Malfunction  
Event Description

Additional information was received that the serial number was previous provided was incorrect. Review of programming history from the study site's handheld showed that the patient was programming to those settings and they did not spontaneously change as initially reported.

 
Manufacturer Narrative

The initial report reported the serial number for the generator which was provided by the site but later it was learned the serial number was incorrect.

 
Event Description

It was initially reported during a (b)(4) that a canine participant's generator settings spontaneously change. This generator model is the same model generator that is currently approved for commercial distribution. It was reported that on two occasions, the canine participant's pulse width value spontaneously changed when the output current value was intentionally programmed. On one occasion the pulse width reportedly changed from 250 usec to 500 usec and on the other occasion the pulse width reportedly changed from 250 usec to 750 usec. Further follow up reported that there were no programming handheld response issues. Additionally, the new pulse width values reportedly did not appear altered on the programming handheld software screen prior to reprogramming with the new output current. There were no reported adverse events related to the change in settings. Good faith attempts for additional information including programming history from the clinical study site are currently underway.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2840042
Report Number1644487-2012-03055
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Study,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number103
Device LOT Number202013
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/09/2012
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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