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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Mechanical Problem
Event Date 01/26/2016
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery in (b)(6) 2016, the surgeon observed an abraded opening on the outer silicone tubing. The inner tubing was noted to be still intact initially and pre-operative system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s lead had been placed on the right vagus nerve at the previous lead replacement surgery due to scarring on the left vagus nerve. The physician elected to replace the lead prophylactically during the procedure and implanted the replacement lead on the right vagus nerve. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Additional information was received from the caregiver that during the past lead revision surgery in (b)(6) 2016, the lining around the wire came off, frayed and was stuck in patient's chest, which required a 6 hour surgery. Per mother, the surgeon stated that he had never seen this happen before with vns. Upon investigation, the operative time was 3. 77 hours with the incision starting on 11:47 and closing 15:33. Operative notes were provided, which indicated that the surgeon found the lead to be degraded. Per notes, finding of degraded leads required replacement of the entire device rather than simple replacement of the left-sided battery. The leads coming from the right side, traversing the clavicle, were found and these plunged through the muscle where they traveled to the implantable pulse generator which was under the muscle in the axilla. When these were found, the exposed leads appeared to be intact. The generator was disconnected from the leads. Surgeon then pulled the disconnected lead toward the medial incision and, at this point, saw that the portion of the lead that had been under the muscle was frayed and bare wires were exposed. Surgeon cut the excess lead out, irrigated the wounds copiously with bacitracin-containing solution, and closed the subcutaneous tissue with. The surgeon was able to see the vagal nerve stimulator leads around the vagal nerve which was encased in abundant scar tissue. A new lead was then implanted.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6495945
Report Number1644487-2017-03619
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2010
Device MODEL Number302-20
Device LOT Number200485
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/02/2007
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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