MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 04/10/2019

Event Type  malfunction  

Event Description

An implant form was received reporting explant and replacement of a patient's generator and lead.The form marked that the lead replacement was due to high impedance "bottom coil not attached".The reason for the generator replacement was not indicated on the form.Further follow up confirmed that the generator replacement was prophylactic.The explanted product has not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

Report source, corrected data: initial report inadvertently did not list that a "foreign" medical facility was involved as a report source.

Event Description

After further follow up with the explanting facility, it was discovered that the explanted generator and lead had been misplaced and will not be returned.No other relevant information has been received to date.

Event Description

It was reported that the explanted generator was going to be returned and that it was unknown if the lead was also going to be returned.The explanted products have not been received by the manufacturer to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8854840
• MDR Text Key: 153091565
• Report Number: 1644487-2019-01486
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2010
• Device Model Number: 302-20
• Device Lot Number: 200588
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR