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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 12/21/2012
Event Type  Malfunction  
Event Description

It was initially reported that the patient was referred for generator replacement due to an unknown reason. On the date of surgery on (b)(6) 2013, the company representative became aware that high lead impedance was observed on (b)(6) 2012 by the referring vns physician. Per the most recent clinic notes on (b)(6) 2012, the notes stated that high lead impedance and limited output status was observed, "suggesting either weak battery (but still functioning) or lead impedance. X-rays were obtained and showed no disconnect". The patient reported to be seizure free for two years. He was reportedly doing well and having no problems, per the physician's notes. The surgeon was not aware of any trauma that may have contributed to the high impedance. Intra-operatively, the surgeon replaced the generator which still resulted in high lead impedance. Therefore, the lead was replaced and retested. Two system diagnostic tests were performed and were within normal limits. The explanted generator and lead were received by the manufacturer for analysis; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as lead discontinuity. Ap and later views of the neck and the chest were received and reviewed by the manufacturer. The generator was visualized in the left side of the patient's chest and placement appeared to be normal. The connector pin appeared to be seen past the connector block and filter feed thru wires were intact. The lead appeared intact at the connector pin. There was a small portion of the lead behind the generator and continuity in that portion of the lead body could not be assessed. Leads were visualized towards the left side of the neck area. There were no sharp angles or lead discontinues seen in the portions of the lead that were able to be visualized based on the x-ray image provided, a cause for the high lead impedance could not be identified however the presence of a micro fracture in the lead or a lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out.

Event Description

Product analysis of the explanted devices was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The device was not turned off as a result of the high impedance. An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis, and therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 207mm portion the end of quadfilar coil 1 appeared to be broken approximately 150mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining quadfilar coil strands was identified as being mechanically damaged and pitted which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed on the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, 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 Key2949056
Report Number1644487-2013-00322
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2005
Device MODEL Number302-20
Device LOT Number009342
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/21/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial