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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 09/30/2014
Event Type  Malfunction  
Event Description

Analysis of the returned generator and lead was completed. No abnormal performance or any other type of adverse condition was found with the pulse generator. The abraded openings and slice mark found on the outer silicone tubing of the returned lead portion most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The slice mark found on one of the inner silicone tubes most likely provided the leakage path for the dried remnants found inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the second inner silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. There is no evidence to suggest a discontinuity in the returned portion of the device. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the vns patient¿s device was explanted and replaced due to unknown reasons. Follow-up clarified that the patient¿s device was tested and diagnostic results revealed high impedance. The patient previously had a mole removed from her back using diathermy and it was believed that the procedure had damaged the patient¿s device. During the replacement procedure on (b)(6) 2014, the replacement generator was tested with the existing lead and system diagnostics still showed high impedance. The patient¿s lead was then replaced and the high impedance condition was resolved. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4213254
Report Number1644487-2014-02888
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number302-20
Device LOT Number200788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/27/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/06/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2008
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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