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

Model Number 304-20

Device Problems Fracture (1260); Mechanical Problem (1384); Low impedance (2285); Device Contamination with Body Fluid (2317)

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

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported on that the patient was referred for lead revision due to low impedance and then underwent full revision due to the generator being found depleted in pre-operatively.It was noted that the battery depleted within 8 months of being implanted.However, it was seen from session reports provided that the pre-operative battery was ok and later in the day battery showed low.It was noted that the surgery started around 9 am and it was a long procedure to change the lead due to fibrosis and adhesions.Electrocautery tool was used.Images showed evidence of abraded insulation.The explanted devices have not been received for analysis to date.No additional relevant information has been received to date.

Event Description

It was noted that the patient experienced a device deficiency of low impedance.It was noted that the device deficiency resolved.Product analysis for the lead 304-20 sn (b)(6) was completed and approved.Abraded openings were identified in the inner and the outer silicone tubing of the returned lead resulting in portion of the lead coils being exposed and tangled.Scanning electron microscopy images of the negative coil show appearance indicating that a stress-induced fracture (due to rotational forces) has occurred at the end of the of the negative coil.Mechanical damage was noted in the vicinity of the broken strands.Also, secondary stress-fissured were identified in the vicinity of the coil break.The lead assembly has dried remnants of what appeared to have once been bodily fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified punctured openings and the cut end of the returned lead portion.The overall appearance of the lead is consistent with patient manipulation of the implanted device, a ¿twiddler¿.Based on the appearance of the returned lead portions, it is believed that the reported short circuit condition was most likely caused by patient manipulation of the implanted device, a ¿twiddler¿.

Event Description

Generator and lead were received for analysis.Analysis is underway but has not been completed and approved 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: 11049805
• MDR Text Key: 223179410
• Report Number: 1644487-2020-01723
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2016
• Device Model Number: 304-20
• Device Lot Number: 202234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Event Location: Other
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR