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 12/09/2020

Event Type  malfunction  

Event Description

It was reported that during an implant procedure a new lead was found to have a ¿twirl¿ therefore the surgeon decided not to use this for implant.Device history record for the lead was reviewed and showed the lead passed all specifications prior to distribution into the field.The lead has not been received for analysis to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device available for evaluation?; corrected data; initial mdr inadvertently omitted information known prior to submission.

Event Description

Lead was received for analysis.Analysis is currently underway but has not been completed to date.An image received showed abraded insulation that appears to show the insulation is torn additional information received that the the problem was noticed before the lead was manipulated during implant.

Event Description

Product analysis for the lead was completed and approved.An analysis was performed on the returned lead portion.During the visual analysis the (+) white and (-) green helices appeared tangled; the green (-) electrode ribbon has a crease.This most likely occurred due to manipulation of the lead during the attempted implant procedure.The anchor tether, (+) white and (-) green electrodes were mounted onto lead training fixture and no issues were observed.The abraded insulation allegation was not confirmed.However, a cut on (-) tubing and coil was observed.The cut appears to have been made by a sharp object which could have occurred during the attempted implant/explant procedure; however, this cannot be confirmed.The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure.Other than the noted tangled helices, and (-) tubing and coil cut, no other obvious anomalies were noted.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11117242
• MDR Text Key: 225102550
• Report Number: 1644487-2021-00019
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 304-20
• Device Lot Number: 205239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Event Location: Other
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1