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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 06/06/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement for end of service the lead was found wrapped/coiled around the generator and was frayed. The surgeon did not want to replace the lead at this time due to the scar tissue and never having performed this operation before. The surgeon believed that the scar tissue was from the initial vns implant. The explanted lead and generator have not been received for analysis to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received that the patient was no a ¿twiddler:¿ the surgeon was not comfortable performing a complete revision and just explanted the generator and part of the lead that is being returned. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that product analysis was completed on the generator. Based on the electrical test results, the generator exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to a near-end-of-service (neos) condition. A battery life estimation resulted in 1. 00 years remaining before the near-end-of-service (neos) flag would be set. However, an incomplete programming/diagnostics history (4. 5-year gap) indicates the estimation does not use all the data required to make an accurate estimation. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Abraded openings were noted in the outer and the inner silicone tubing of the lead coils resulting in portions of the lead coils being exposed and fluid being found in the inner and outer tubing. Also, the lead coils have wear (flat surfaces) at the lead body. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the area where the wear (flat surfaces) was noted. Scanning electron microscopy image of the negative coil show that wear (flat surfaces) occurred in the vicinity of the loop. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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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 Key3913659
Report Number1644487-2014-01699
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/06/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1354
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/26/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/2005
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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