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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem Scar Tissue (2060)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that the patient had surgery for a battery replacement.During the surgery, it was observed that a portion of the lead (located behind the generator) was not intact.Following diagnostics, high impedance was observed.A lead replacement was then initiated, however, a portion of the nerve was also observed to not be intact.The surgeon ultimately decided to fully explant the vns system.Response was received from the surgeon regarding the patient surgery.The surgeon reported that the insulation of the lead appeared to be broken down, resulting in the lead being exposed.When the lead revision was initiated, the surgeon observed scar tissue on the nerve (which was expected).As the electrodes were attempted to be removed, the surgeon identified that there was a disconnect between the nerve and the electrodes due to a thickening of the nerve (resembling a neuroma).After discussion, it was decided to abandon the revision as the repair of the nerve would likely not be successful.The surgeon also noted that the patient remained unharmed.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has anydefects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Product analysis (pa) was approved for the lead, which was explanted and returned due to a reported high impedance.The event of high impedance was not confirmed by pa.Two portions of the lead assembly were returned as well as one tie down.Dried remnants were visually observed inside the inner and outer tubing.Abrasions were observed in various areas, but no obvious point of entrance (other than the cut and torn ends of the returned portions) was noted.Two sets of set setscrew marks were observed on the connector pin.The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead at one point in time.The end of the outer and inner silicone tubes appeared to be cut and torn; ring and pin inner tubes have penetrating slice cuts near end of tubing.The pin coil extends out of tubing, is stretched, and the end appears to be cut.The ring coil end appears dark and melted.It is possible the thermally damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of this lead.Continuity checks on the returned lead portions were performed, and no discontinuities were identified.Other than the melted coil end, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Based on the findings in the pa lab, other than typical wear and explant related observations, no anomalies were identified on the returned lead portions.

Event Description

Response was received from the physician that the observed scarring was likely due to the patient's initial implant surgery.No other 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: 16799537
• MDR Text Key: 313862177
• Report Number: 1644487-2023-00508
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2017
• Device Model Number: 302-20
• Device Lot Number: 202539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 04/26/2023; 05/30/2023
• Supplement Dates FDA Received: 05/19/2023; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male