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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 06/01/2012
Event Type  Malfunction  
Event Description

On (b)(4) 2012, it was reported that there were complications during this vns patient's surgery on (b)(6) 2012, and high impedance was seen. Follow up with the physician on (b)(4) 2012 revealed that high impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service; however, the high impedance was not acknowledged. Pre-operative diagnostics were not run as the surgery was scheduled to be a battery replacement. Operative notes were also received on (b)(4) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient's surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced. On (b)(4) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.

Event Description

On (b)(6) 2012, it was reported that no patient manipulation or trauma was known to have preceded the high impedance event. The explanted lead was received on (b)(6) 2012. Product analysis was approved on (b)(6) 2012. The reported fracture of lead allegation was not verified within the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the discolored region noted in the vicinity of the coil cut end. The exact reason for this condition is unknown. Also, it was verified that the coil was cut. The lead assembly had remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was noted other than the cur end of the returned lead portion. Four sets of setscrew marks were seen on the connector pin, provided evidence that proper contact between the setscrew and the lead pin existed at least once. Note that since a portion of the lead (including the electrode array) 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 typical wear and explant related observation, no other anomalies were identified in the returned lead portion.

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.

Manufacturer Narrative

Device failure is likely, 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)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2676357
Report Number1644487-2012-01923
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number302-20
Device LOT Number2107
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/03/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 07/31/2012 Patient Sequence Number: 1