MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

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

Event Date 11/17/2020

Event Type  malfunction  

Event Description

It was noted that during the scheduled replacement generator, an output current of 2.0ma was the highest current able to be programmed before high impedance and low output current were observed.A deformation in the lead was observed during the generator replacement surgery.The patient was referred for a full revision.A full revision performed on a later date.During the revision, there was a large knot in the suspect lead observed and the lead snapped when trying to remove generator.The lead was revised and impedance was observed to be within normal limits after the replacement surgery.The explanted devices have not been received to date.No additional relevant information has been received to date.

Event Description

Lead lot number and manufacture date were received.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

The explanted devices were received.Product analysis is being performed.No additional relevant information has been received to date.

Event Description

Generator and lead analysis was performed.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.A break was identified at the ends of both the positive and the negative lead coils.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location.A secondary broken strand was identified in the vicinity of the coil broken end.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location.The negative coil show appearance suggesting that a stress-induced fracture (fatigue) has occurred in at least two strands of the quadfilar coil.A kink was observed.The inner silicone tubing was worn out and abraded open at break locations.Note that a portion of the lead assembly (body) including the electrode array section was not returned for analysis, and therefore an evaluation and resulting commentary cannot be made on that portion of the lead.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10995394
• MDR Text Key: 221232517
• Report Number: 1644487-2020-01666
• 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,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2003
• Device Model Number: 300-20
• Device Lot Number: 4398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Event Location: Other
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR