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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); High impedance (1291); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

The patient presented with high impedance.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

X-rays were reviewed.The generator placement was determined to be in the upper left chest.Based on the images provided, the feedthrough wires were intact, and the pin could not be visualized past the second connector block.The lead was visualized in the chest and neck.There appeared to be a strain relief bend however there was no loop present per labeling.Two tie downs were observed which is not per labelling since there is not a third tie down securing a strain relief loop.A portion of the lead was visualized to be routed behind the generator.The lead was assessed for fracture and discontinuities on the visible portions of the lead however none were noted.The lead wires appeared to be intact at the connector pin.Based on the x-rays received, the cause of the high impedance is likely incomplete pin insertion; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient presented to surgery and pre-op diagnostics showed high impedance (6993 ohms).The generator had been off since the high impedance was first detected.The surgeon had some difficulty getting access to the generator due to adhesions in the pocket and the generator eventually became disconnected from the lead without using the screwdriver (confirming that the pin was loose).They used the test resistor with the existing generator and impedance was ok.When attempting to re-connect it to the lead, the generator was accidentally dropped.A new generator was opened and connected to the lead, diagnostics were performed and impedance was high >10,000 ohms.They confirmed proper pin insertion.The lead was then replaced as well.System diagnostics with the new implant were ok.It was noted that there was no obvious fracture with the old lead and there was fibrosis near the electrodes.The explanted suspect product was received but product analysis has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the generator.No obstructions were observed in the header lead cavity or the connector blocks.The in-line cavity go gauge test passed and a bench lead fully inserted into the generator header (past the negative connector block) (lab conditions).Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Product analysis was completed on the lead.During the visual analysis of the first portion, the ring coil was found to be broken.The coil breakmate was found on second portion.The broken ends of the coil show appearance suggesting that a stress-induced fracture has occurred.However, the exact fracture mechanism cannot be ascertained.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing, in some areas.No obvious point of entrance was noted other than the identified tube openings and the cut and torn ends of the returned lead portions.Pitting is visible at the coil break location.Continuity checks of the returned lead portions were performed during the functional analysis, and no other discontinuities were identified.Other than the above noted observations, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Note that since the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No further relevant information has been received to date.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12976199
• MDR Text Key: 284281317
• Report Number: 1644487-2021-01717
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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: 67 YR
• Patient Sex: Female