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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 11/20/2018

Event Type  malfunction  

Event Description

A patient's device was explanted for an unknown reason.It was indicated from the return product form that the replacement was prophylactic.Analysis was completed for the returned generator.The device was confirmed to be at eos, which was expected due to the generator remaining "on" post-explant.Review of the data downloaded from the generator showed a high impedance.Programming history showed ok diagnostics prior to the noted high impedance.No additional, relevant information was received to date.

Event Description

Further follow up with the patient's nurse confirmed that the patient's device was truly explanted for prophylactic replacement on (b)(6) 2017, which means that the high impedance registered on the data download from the generator occurred after explant and is most likely related to the explant procedure.Additionally, it was confirmed that device diagnostics were performed just prior to the surgery and confirmed that all diagnostics were within normal limits.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8547777
• MDR Text Key: 143587320
• Report Number: 1644487-2019-00772
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2019

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: 11/24/2005
• Device Model Number: 302-20
• Device Lot Number: 009637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR