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Model Number 300-20
Event Date 04/16/2012
Event Type  Malfunction  
Event Description

The company representative reported that the surgeon pulled the lead when installing the new generator, making the lead taut. After closing the patient and waking her, the patient was in pain as a result of the tautness when she turned her head to the right. The surgeon opted to take the patient back in to surgery to correct. Surgeon used electrocautery and cut the lead at that time. The surgeon noticed that he had cut the lead immediately and damage was visible. The surgeon noted that no injury to the vagus nerve was observed. He did not opt to perform full revision. Therefore, the patient's device was disabled and was never programmed. The patient was referred to a different facility for full revision. The physician noted that patient was a little hoarse following surgery which is believed to be related to surgery, but there was no paralysis believed to be present. No serious injuries occurred, and no interventions were taken to preclude a serious injury. The hospital discards products in surgery, so attempts for product return of the explanted generator on (b)(6) 2012, were unsuccessful. The patient had generator and lead replacement surgery on (b)(6) 2012. Pre-op system diagnostics indicated high lead impedance. The surgeon displayed the x-ray in the operating room, and a lead discontinuity was visible near the generator area. Two system diagnostics on the newly residing generator (one out-of-pocket and one in-pocket) indicated okay results. The field clinical engineer confirmed that the generator was replaced for compatibility to the single pin lead. The explanted generator and lead on (b)(6) 2012, were received by the manufacturer. Product analysis for the generator and lead was completed. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis of the lead identified a coil discontinuity in the positive coil. Scanning electron microscopy images of the positive coil suspected broken ends show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in both coil ends. The suspected coil break is located at approximately 8. 3cm from the end of the connector bifurcation. This was most likely caused during the implant/explant procedure, as reported by the company representative who attended the surgery. Also, the positive coil has what appears to be wear (flat surfaces) in the vicinity of coil discontinuity. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred on the coil in the vicinity of the identified flat surfaces. The outer silicone tubing has what appears to be an imprint at approximately 8. 3 cm from the end of the connector bifurcation. The exact reason for this imprint is unknown. Also, the inner silicone tubing of the positive coil has what appears to be tearing at this location. The unmarked connector pin has what appears to be pitting in the vicinity of the setscrew marks. The inner silicone tubing of the positive coil is abraded open at approximately 8. 1-8. 4 cm from the end of the connector bifurcation. 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 (besides an abraded inner tubing opening) were identified in the returned lead portion.

Manufacturer Narrative

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

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key2697273
Report Number1644487-2012-02005
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2001
Device MODEL Number300-20
Device LOT Number29775C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2012
Event Location Other
Date Manufacturer Received07/23/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/08/1999
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial