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

Model Number 300-20

Device Problems Low impedance (2285); Electrical Shorting (2926)

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

Event Date 12/14/2021

Event Type  malfunction  

Event Description

During a battery replacement upon dissection of the generator pocket, it was found that the generator was sitting on a calcified plate, exposing lead degradation.Once a new generator was implanted, low impedance was seen.Two days later the patient then underwent a full revision.The explanted products have not been received by product analysis to date.No other relevant information has been received to date.

Event Description

The explanted generator and lead were received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator and lead.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 3.055 volts, and the memory locations on the generator indicated that 3.471% of the battery had been consumed.There were no performance, or any other type of adverse condition found with the pulse generator.The lead analysis was completed but note that since a significant portion of the lead assembly (body) including the electrode array section was not returned for analysis, a complete evaluation could not be performed on the entire lead product.The reported low impedance was partially confirmed in the pa lab.A low impedance condition was identified due to exposed intertwined conductive coils, however that condition likely occurred during explant procedure.With the exception of the noted conditions above, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were identified in the returned lead portions.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13122120
• MDR Text Key: 285749228
• Report Number: 1644487-2021-01852
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

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: 05/08/2000
• Device Model Number: 300-20
• Device Lot Number: 10987C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/07/2022; 02/09/2022
• Supplement Dates FDA Received: 02/01/2022; 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/1998
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male