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

Model Number 302-20

Device Problems Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 10/21/2020

Event Type  malfunction  

Event Description

Patient underwent full revision surgery.During the surgery, the surgeon noted a visible break in the lead and also moisture was seen in the lead.The explanted products have been received but product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Generator analysis was completed on the returned device.Results of diagnostic testing indicated the device was operating properly and communicated properly.Electrical test results showed that the pulse generator performed according to functional specifications.The pa worksheets were reviewed and no anomalies were noted.There were no adverse functional, mechanical, or visual issues identified with the returned generator.The lead was explanted and returned due to reported pain and product analysis was completed.Note that since a portion of the lead (including) the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.An abraded opening was identified in the outer and the inner silicone tubing of the negative coil.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings.The lead fracture allegation was not duplicated in the pa lab.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10836034
• MDR Text Key: 216118850
• Report Number: 1644487-2020-01515
• 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
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2013
• Device Model Number: 302-20
• Device Lot Number: 201156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Event Location: Other
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR