MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem High impedance (1291)

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

Event Date 06/09/2018

Event Type  malfunction  

Event Description

An implant card was received confirming that a patient underwent a full lead revision procedure due to high impedance.The surgeon does not have an assessment on the cause for high impedance, as the lead did not appear to be broken.The leads were initially replaced; however, the high impedance was still registering on the patient¿s vns system, while the old generator was implanted with the new leads.The surgeon attempted several lead pin reinsertions and ran a diagnostics with the test resistor inserted, but the high impedance did not resolve.It was noted that the problem fixed when the surgeon changed out the generator and rebooted the tablet.It was mentioned that during pin re-insertion attempts the header was inspected for possible obstructions, the setscrew was backed out adequately, and the surgeon heard the clicks when tightening the setscrew with the screwdriver.Additionally, it was noted that the surgeon visually inspected the lead for breaks in the system, and that upon visual inspection no breaks or fractures were observed.A device history record review of the generator indicated that all quality inspections were performed and passed.The lead fracture has been reported in mfg report # 1644487-2019-00640.The explanted product has not been received to date, and it was noted that the hospital does not have the device available for return to the manufacturer.No other relevant information has been received to date.

Event Description

Programming data was received from the programmer used during the patient's surgery.It was observed that no diagnostic testing was performed during the patient's surgery to confirm the observed impedance readings.Please note that a system diagnostics test should be performed to confirm the lead impedance values, and a generator diagnostics test (pre-implant test) should be performed with the test resistor to verify the generators impedance values, independent of the lead.The explanted product has not been received to date, and it was noted that the hospital does not have the device available for return to the manufacturer.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 8493520
• MDR Text Key: 141314726
• Report Number: 1644487-2019-00674
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2010
• Device Model Number: 103
• Device Lot Number: 200994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2009
• 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