MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion, Clonic (2222)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

It was reported that the patient could not feel magnet stimulation so they had their device checked.Normal diagnostics were within normal limits but it was indicated that the magnet was not testing normally.An increased in seizures were also reported for the patient so they were referred for a battery replacement.The patient underwent surgery and received a full revision.The explanted products have not been received by product analysis to date.No other relevant information has been received to date.

Manufacturer Narrative

H6 adverse event problem codes, corrected data: initial report inadvertently left out a type of investigation code.

Event Description

Additional information received from the physician's assistant noting that the cause of the increased seizures were alleged against the lead wire being found to be twisted.The explanted devices were not made available for return.

Manufacturer Narrative

B1 adverse event or product problem, corrected data: supplemental #02 mdr report inadvertently did not select product problem.H1 type of reportable event, corrected data: supplemental #02 mdr report inadvertently did not select malfunction.H6 adverse event problem codes, corrected data: supplemental #02 mdr report inadvertently did not code d14.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12210685
• MDR Text Key: 262893953
• Report Number: 1644487-2021-00985
• 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,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2003
• Device Model Number: 300-20
• Device Lot Number: 3302
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 08/17/2021; 10/19/2021
• Supplement Dates FDA Received: 08/17/2021; 09/10/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR