MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 02/20/2020

Event Type  malfunction  

Event Description

Patient underwent a generator replacement due to normal expected battery depletion and once the new generator was connected, the impedance was within normal limits.While in recovery the patient noted that they could not feel stimulation so a system diagnostics was performed and high impedance was observed.The patient underwent a lead revision and it was noted that the "insulation was completely broken around the lead wires at the edge of an old white tie down tab".Following the lead revision the impedance was within normal limits.The explanted products have been received by the manufacturer, but product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.During the visual analysis abraded openings were observed on the outer and inner silicone tubes.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting.Pitting and residual material were 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.The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.With the exception of the abraded openings and observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.

Event Description

Generator analysis completed on the returned explanted device.The electrical tests performed in the pa lab found that the generator was not at end of service.Evaluation of the explanted pulse generator¿s reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse conditions found with the pulse generator, and the pulse generator performed according to functional specifications.Product analysis has not been completed to date on the suspect product (lead).

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9836566
• MDR Text Key: 187947774
• Report Number: 1644487-2020-00451
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2005
• 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