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

Model Number 302-20

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Patient had a prophylactic generator replacement.It was noted during surgery that there was a kink/bend in the lead wire.Diagnostics were within normal limits.The surgeon decided not to replace the lead at that time.No additional relevant information has been received to date.

Event Description

Per the surgeon, the cause of the kink could not be provided.The lead passed all functional specifications and quality tests and were sterilized prior to distribution.No known surgery has occurred to date.No additional relevant information has been received.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12470870
• MDR Text Key: 271469593
• Report Number: 1644487-2021-01294
• 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: 10/08/2021

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: 07/21/2004
• Device Model Number: 302-20
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR