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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 10/28/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostics revealed high impedance. At the patient¿s previous office visit on (b)(6) 2013, system diagnostics showed lead impedance within normal limits. X-rays were taken and were reported by the physician to show possible looping/interruption in the lead behind the 3rd rib. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator and lead was completed. The as-received generator was completely detached from the header which occurred during and after explant surgery. Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator. Lead discontinuity was confirmed in both positive and negative quadfilar coils in the body region of the returned lead portions. Scanning electron microscopy images show that at pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed in both outer and inner tubing near the break locations. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 Key4280149
Report Number1644487-2014-03152
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2005
Device MODEL Number302-20
Device LOT Number7631
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2003
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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