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

Model Number 304-20

Device Problems Fracture (1260); Migration (4003)

Patient Problem Convulsion, Clonic (2222)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Patient's generator was found to be at eos and high impedance was observed.System diagnostics were unable to be performed as the generator was pulse disabled.It was reported that the patient was having several seizure due no longer receiving therapy from the battery depletion and high impedance.When opening the chest pocket during surgery, the lead was observed to have tears and kinks.When the generator was pulled from the pocket, the lead was seen to be completely severed.Per hospital policy, the explanted devices were discarded.No additional relevant information has been received to date.

Manufacturer Narrative

F10.- correction - f1905 & a010402 should have been included in initial mdr.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12177496
• MDR Text Key: 261826796
• Report Number: 1644487-2021-00960
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2016
• Device Model Number: 304-20
• Device Lot Number: 202308
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR