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

Model Number 302-20

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

Patient Problem Fibrosis (3167)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

During a generator replacement due to battery depletion, the patient presented with high impedance once the new generator was connected to the lead (captured in this mfr.Report).Pre-op diagnostics could not be performed to determine the impedance, since the patient's generator had reached end of service.The leads were adjusted, the surgeon checked for any visual fractures, took steps to relieve back pressure, made sure the nerve was irrigated and multiple system diagnostic tests were performed but high impedance was still observed.Generator diagnostics were performed with a test resistor and the impedance was normal, so a generator issue was ruled out.The surgeon then replaced the lead and checked for correct placement on the nerve and high impedance was still observed, this is captured in mfr.Report #1644487-2020-00141.The lead was then replaced again and high impedance was still observed and the patient was closed, this is captured in mfr.Report #1644487-2020-00140.A review of device history records was performed and revealed that the lead passed quality control inspection prior to distribution for the lead that was opened but not used.The surgeon then mentioned that she is unsure of the cause of the high impedance, but a fairly thick layer of fibrous tissue was observed on the patient's nerve.The explanted generator and lead has been received by pa, but product analysis has not been completed to date.No further surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.Note that the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.A break was identified on the positive coil.Scanning electron microscopy images performed on the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break location.Due to metal dissolution and/or surface contamination the fracture mechanism of the broken wires cannot be ascertained.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing.No obvious point of entrance was noted other than the identified tubing opening and the cut ends of the returned lead portions.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Product analysis was completed on the returned generator.The electrical tests performed in the product analysis(pa) lab found that the generator was partially depleted and not at end of service (eos), despite the elective replacement indicator (eri) flag being set.The low battery voltage condition was the result of normal, expected battery depletion.The device was able to be interrogated and found to be at near end of service=yes.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.

• 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: 9648520
• MDR Text Key: 183965939
• Report Number: 1644487-2020-00142
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2009
• Device Model Number: 302-20
• Device Lot Number: 200121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2006
• 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: 53 YR