MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.X-rays were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator and could not be assessed.No clear lead breaks were found in the parts of the lead that could be assessed; however, there was a suspect area in the lead portion near the tie-downs.Due to the quality of the images received, the lead wire could not be completely assessed.Based on the images provided, the cause of the high lead impedance remains unknown.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received stating that the x-ray images were reported by the physician to be unremarkable.The patient¿s device was tested again during an office visit on (b)(6) 2014 and system diagnostic results again showed high impedance.The patient¿s device was subsequently disabled.The patient was not able to pinpoint any previous events that may have caused or contributed to the high impedance.

Event Description

Additional information was received indicating that the patient was to undergo explantation of her vns system.It was reported that the physician and patient's family decided not to continue vns treatment since the patient's seizures did not worsen after turning vns off.The patient's vns system was explanted on (b)(6) 2015.The explanted pulse generator and lead have been returned to the manufacturer and are currently undergoing product analysis.

Manufacturer Narrative

Explant date.If explanted, give date (mo/day/yr), corrected data: this information was inadvertently not included in manufacturer's supplemental report #2.

Event Description

Analysis showed that the quadfilar coil of one returned portion appeared to be broken approximately 12mm from the end of the cut inner silicone tubing.The fracture surface exhibited extensive pitting which prevented identification of the coil fracture type.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Setscrew marks observed near the end of the connection pin indicate that the lead had not been fully inserted into the header cavity of the generator at one time.The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.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 those described.No anomalies were noted with the returned pulse generator.

• Brand Name: LEAD MODEL 302
• 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: 3957908
• MDR Text Key: 4624916
• Report Number: 1644487-2014-01870
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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: 12 YR