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

Model Number 304-20

Device Problem Fracture (1260)

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

Event Date 10/07/2019

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on a system diagnostic test and the patient's mother reported that the patient had two falls three weeks before the believed to due to a generalized seizure with bruising on her left side.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient's generator was replaced due to prophylactic reason.There was no indication that the lead was replaced.The patient's generator showed normal impedance at the end of surgery.No additional relevant information has been received to date.

Manufacturer Narrative

H2.If follow-up, what type ; corrected data: "correction" was inadvertently not selected on supplemental mdr #2.

Event Description

Generator analysis was approved and reviewed.The generator was explanted due to prophylactic replacement and no malfunction.Various electrical loads were attached to the generator and results of the diagnostics tests demonstrate that accurate resistance measurements were obtained in all instances.There were no performance or any other type of adverse condition found with the generator.No additional relevant information has been received.

Event Description

Information was received that incomplete pin insertion was not noted at the time of generator replacement.The explanted generator has been received into analysis however analysis has not been completed 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: 11283571
• MDR Text Key: 230450065
• Report Number: 1644487-2021-00168
• 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,Followup,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 304-20
• Device Lot Number: 5064
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR