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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 06/11/2012
Event Type  Injury  
Event Description

It was reported that a vns patient was going to have their lead replaced related to neck pain and migration of their electrodes. The patient had been complaining, for almost 1 month, of increasing neck pain and obvious increasing prominence of the lead anchors under her skin. There didn't seem to be an effect of stimulation on the pain and there was no increase in seizure frequency. There was no history of trauma that preceded the lead migration or pain. X-rays confirmed the leads being almost horizontal in the neck, suggesting that some/all leads were not on the vagal nerve. X-rays were not provided to the manufacture for review. In the operating room, the generator was inconsistent on interrogation - sometimes the surgeon could get a baseline read on the settings, and other times would get an eos warning, or no response. Based upon this, the generator was replaced with a new m103. During surgery, the anchors in the neck were still in position with non-dissolvable sutures still in place. The anchors appeared to have been anchored to the surface of the sternocleidomastoid muscle, explaining their obvious prominence. The leads were still wrapped on a nerve, but the incision was very low, and the nerve was not the main trunk of the vagus, likely a distal branch. The jugular vein was not present lower in the neck and was a tiny vein higher up. The lead was removed and the anchor and the surgeon was able to follow the carotid upwards and isolate a length of vagal nerve above the previous surgery site. He then hooked up the leads to generator and reprogrammed the new generator to the last known settings. The physician felt it was possible the vns leads were implanted too low in the neck on a distal branch of the vagus, and anchored just under the skin. He also wondered if the jugular vein was injured or sacrificed during that surgery. The patient will be monitored following surgery to see if their pain resolves. Good faith attempts were made for the explanted product and it was not returned for analysis.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD MODEL 303
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2643048
Report Number1644487-2012-01701
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number303-20
Device LOT Number3004
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/12/2012
Event Location Other
Date Manufacturer Received07/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/11/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2012 Patient Sequence Number: 1
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