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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Fracture; Lead
Event Date 11/11/2013
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Initially, it was reported that the patient underwent device explant for an unknown reason. Further follow-up revealed that the vns system was explanted because the device had been programmed off for some time because it was painful when the device was on. It was noted that during explant there was a lead fracture visualized by the surgeon near the neck area. The patient was not reimplanted. The explanted lead and generator were received for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

 
Event Description

Follow-up revealed that the patient first reported painful stimulation in the neck during an office visit on (b)(6) 2013. The device was subsequently disabled. No diagnostic tests were performed that day. The last diagnostic test was performed on (b)(6) 2013 which showed normal device function at that time and the device had not been tested since device disablement.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key5000874
Report Number1644487-2015-05471
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number304-20
Device LOT Number201852
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/18/2011
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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