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

Model Number 304-20

Device Problem Low impedance (2285)

Patient Problems Twitching (2172); Convulsion, Clonic (2222); No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  malfunction  

Event Description

The patient's device showed low impedance.The patient was unable to perceive vns stimulation and did not experience voice alteration that was typical of stimulation for her.The patient was interrogated in various positions (standing up, laying down, turning her neck) and the low impedance never resolved.The patient has had no trauma or manipulation of the lead.No known surgical intervention has been received to date.No other relevant information has been received to date.

Event Description

Further assessment was received from the doctor who stated that given the detection of an abnormally low lead impedance, a recent seizure, and the patient & #39;s report of muscle twitching around the vns, he suspects a lead malfunction causing an intermittent short circuit.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10456778
• MDR Text Key: 204538644
• Report Number: 1644487-2020-01131
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2015
• Device Model Number: 304-20
• Device Lot Number: 201801
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR