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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problem Seizures (2063)

Event Date 11/26/2020

Event Type  malfunction  

Event Description

It was reported that the patient had high impedance (>10,000 ohms).It was noted that on thanksgiving the patient had a fall, and shortly after that she started feeling stimulation in her neck that seems to be not in the right spot as it is lower than the electrodes.The feeling is not painful.About 3 weeks ago she started having increased seizures.The patient then saw pa last week and high impedance was observed so the device was turned off.The device was turned back on temporarily and the patient again felt the stimulation in her neck.The physician believes there is a fracture in the lead but they were not able to confirm anything on x-rays.Ap/lateral x-rays of the chest and neck were received and reviewed.The x-rays were provided because the patient had high impedance >10,000 ohms reported shortly after a reported fall.The placement of the generator in the upper left chest was normal and the feedthru wires appeared to be intact.The lead was routed behind the generator.The connector pin cannot be visualized to be fully past the connector block.The visible portion of the lead was assessed.No obvious gross fractures or microfractures were observed; however, there was a small portion of the lead right above the generator that appeared to be twisted.Based on the x-rays provided, the cause of the high impedance may be due to the connector pin not being fully inserted and a portion of the lead being twisted.Note that the presence of a lead discontinuity the portion of the lead that is not visible in the provided images and/or a microfracture cannot be ruled out.No known surgical intervention has occurred to date.

Event Description

The patient had a full replacement.The explanted devices are not available for return for analysis.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11285246
• MDR Text Key: 232166865
• Report Number: 1644487-2021-00175
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2018
• Device Model Number: 304-20
• Device Lot Number: 3886
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR