MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Discomfort (2330)

Event Date 05/12/2012

Event Type  malfunction  

Event Description

Clinic notes dated (b)(6) 2015 note that the patient and her mother feel that the vns was injured or disconnected the year prior and that device diagnostics were within normal limits.It was noted that there was a tightness in the lead that the neurologist was concerned about.The surgeon noted that there is no unusual tightness of the lead.An x-rays assessment was received indicating that the lead wire was disconnected from the device in the left neck.It was reported that device diagnostics performed on (b)(6) 2014 were within normal limits (1704 ohms).The neurologist believes that scar tissue is the reason for the lead tightness feeling that the patient experiences.The neurologist indicated that the patient's parents have asked for the generator and lead to be replaced.X-rays were sent to manufacturer for review.X-rays identified that the lead appeared to be fractured near the electrodes.It was later reported that high impedance was observed and that revision surgery was planned.A fluoroscopy was performed by the surgeon who found that the lead could not be seen clearly and concluded that the lead may have never been connected.Recent diagnostics were found in the physician's programming system that showed that device diagnostics were within normal limits at one time which showed that the device was at one time connected.The patient was seen on (b)(6) 2015 at which time device diagnostics were within normal limits.It was reported that the device was functioning normally and was programmed back on.The cause of the diagnostics being within normal limits is a believed short circuit situation with the patient's tissue.A device decoder was performed which identified that the lead break likely occurred as early as (b)(6) 2012.The patient was referred back to surgeon.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Review of x-rays by the manufacturer revealed a gross lead discontinuity.Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Additional x-rays were sent to the manufacturer for review.X-rays identified that the lead appeared to be fractured near the electrodes confirming a lead break.

Manufacturer Narrative

Age at time of event; corrected data: this information was inadvertently reported incorrectly on initial mfr.Report.

Event Description

It was reported the patient has been referred for replacement surgery; however, no surgical intervention has taken place to date.

Event Description

The patient underwent a full vns revision on (b)(6) 2016.It was noted when the lead was removed, it appeared to be fractured and the lead wires were twisted together.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The explanted generator and lead were received by the manufacturer on 03/02/2017.While analysis is expected, it has not been completed to date.

Event Description

Product analysis (pa) for the returned generator was completed.A comprehensive automated electrical evaluation showed the generator performed according to functional specifications, with the exception of the test "backup cap neg to can", which has already been captured in mfr.Report 1644487-2017-03534.There were no additional performance or any other type of adverse conditions found with the generator.Pa for the returned lead was completed.Allegations of lead fractures were confirmed.The electrodes were not returned for analysis; therefore, a complete evaluations could not be performed on the entire lead product.During the visual analysis, the outer silicone tubing appeared to be twisted and compressed in several areas.Fractures were identified and scanning electron microscopy found that they were stress induced fractures.Additionally, pitting was observed on the surface of some of the breaks.Abraded openings found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.Energy dispersion spectroscopy was performed on one of the deposits and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium.With the exception of the observed discontinuities and the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portion of the device, which may have contributed to the stated allegations of lead fractures.Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4749594
• MDR Text Key: 5769025
• Report Number: 1644487-2015-04621
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2002
• Device Model Number: 300-20
• Device Lot Number: 303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/15/2015; 01/08/2016; 12/09/2016; 03/27/2017; 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2000
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR