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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

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

Event Date 04/02/2016

Event Type  malfunction  

Event Description

It was reported by a medical professional that a patient's device was found to have high lead impedance at a surgical consult to replace the patient's generator that was at end-of-service.X-ray images were received by the manufacturer and were reviewed.Based on the images provided, the pin appeared to be fully inserted past the connector block.The feed-through wires appeared intact, and the generator was placed in the upper left chest, as expected.There was a suspect region in the strain relief bend of the wiring where no obvious fractures or sharp angles were identified, however, due to the angle and quality of the images provided, this portion of the lead was difficult to fully assess.A strain relief bend was present and placed per labeling.A strain relief loop was present, but was not placed per labeling.Based on the images provided, there was no obvious cause for the high impedance; however the presence of micro-fractures cannot be ruled out.A full revision surgery was performed.Prior to the surgery, diagnostics on the device were run again and resulted in high impedance.During the surgery, the old generator was removed and the replacement generator was attached to the old leads.Diagnostics were performed again, still showing high impedance.The old leads were explanted, including all three helices from the nerve, and were replaced.The new leads were attached to a new generator and diagnostics showed impedance was fine.Tablet data was also received confirming the high impedance observed on these occasions.Product analysis is underway but has not been completed to date.No other additional or relevant information has been received to date.

Event Description

Product analysis was completed and approved for the returned leads and generator.Lead product analysis: the leads were returned in two parts, and a break was found through a continuity check in one of the electrode coils where the inner silicone tubing appeared to be abraded open and torn in half.Set screw marks were observed on the connector pin, indicating proper connection between the generator and leads.Abraded openings were observed on the outer and inner silicone tubings.Extensive pitting was identified through scanning electron microscopy of the coil strands.With the exception of the abraded openings and 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.Generator product analysis: end-of-service condition was confirmed in the generator and was found to be associated with the output being disabled by the pulse generator, due to an indication of increased impedance prior to explant.Review of the last noted impedance change in the device indicated an impedance change of 9035 ohms to 11957 ohms detected on (b)(6) 2016.Subsequent testing could not be performed as the pulse disabled bit of the generator could not be reset.

• 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: 7237426
• MDR Text Key: 99081489
• Report Number: 1644487-2018-00139
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 10960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2004
• 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: 42 YR