MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Mechanical Problem (1384)

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

Event Date 12/17/2020

Event Type  malfunction  

Event Description

The patient was referred for generator replacement due to low battery, and pre-op diagnostics were normal.Upon opening the chest pocket the surgeon observed cracking in the lead insulation.After further manipulation of the lead, the insulation displaced and the wire was fully exposed but was still intact.The lead and generator were both replaced.It was noted that there was a sharp kink in the lead and when the surgeon released the suture and straightened it out, it revealed the section where the lead degraded.It was noted that the cause of the lead damage was unknown, there was no sign of patient manipulation and the suture was intact.The device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.No other relevant information has been received to date.

Event Description

Information was received that the explanted devices were not discarded.The devices have been received for analysis but product analysis has not been completed on the suspect product to date.No further relevant information has been received to date.

Event Description

Lead analysis was completed.Abrasions were noted on the outer silicone tubing.Kinks were noted on the lead coils.However, the exact point in time when they occurred is unknown.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Generator analysis was completed.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11147352
• MDR Text Key: 226045108
• Report Number: 1644487-2021-00052
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2017
• Device Model Number: 304-20
• Device Lot Number: 202620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Event Location: Other
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR