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

Model Number 304-20

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

During a new patient implant, the surgeon opted to not use the original lead that was going to be implanted as he believed it was bent.The livanova representative that was present noted that the surgeon was working on the negative and positive electrodes for about 20 minutes.While visually inspecting the lead, the rep noticed that the negative electrode is exposed in the coil.The suspect lead was received but product analysis is still underway.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.The allegation of ¿mechanical problem, damaged/kinked coil¿ was not confirmed.During the visual analysis kinks on coils were not observed, however five atypical marks on connector pin, were observed.Also, a scratch on connector ring leading to a cut off portion of first large o-ring was observed.Based on the appearance of the returned lead it is believed that the above-mentioned observations were most likely caused during manipulation of the lead at surgery.Continuity checks of the returned lead portion was performed during the functional analysis, and no discontinuities were identified.Other than the noted above conditions, the condition of the returned lead portion is consistent with conditions that typically exist following an implant/explant procedure.

• Brand Name: LEAD MODEL 304
• 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: 14461859
• MDR Text Key: 292381103
• Report Number: 1644487-2022-00579
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 7021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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: 29 YR
• Patient Sex: Male