MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that during a battery replacement procedure, high impedance was seen with the new generator.It was noted by the surgeon that when trying to perform a pin-reinsertion troubleshooting step it was difficult to unscrew the setscrew; however, the screw finally popped out after it was turned repeatedly.The surgeon decided to use the back-up generator where diagnostics was within normal limits and no issues were observed.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.Suspect device has not been received to date.No other relevant information has been received to date.

Event Description

Suspect device has been received and is undergoing product analysis internal generator data has been received and analysed.High impedance was found after multiple system diagnostics performed during troubleshooting.No other relevant information has been received to date.

Event Description

Product analysis of the returned generator was completed.The visual observations are most likely associated with manipulation of the device during the implant procedures.The returned setscrew socket shows mechanical wear (due to multiple torque wrench insertions) and with some septum debris.The setscrew socket is not stripped.The returned septum shows damage on the underneath side, indicating the setscrew was extracted up into the septum.The returned torque wrench showed no visual anomalies.An interrogation and system diagnostic tests were performed.A comprehensive automated electrical evaluation (shows an ifi=no condition) was performed.There were no performance, or any other type of adverse conditions found with the pulse generator.As pre-operative and back-up generator diagnostics was within normal limits and no performance or any adverse conditions noted within product analysis, it can be concluded that the cause of the high impedance with the suspect generator is due to an incomplete pin insertion.It was noted that the physician attempted to perform a pin-insertion but when the setscrew popped out, they elected to just use the back up generator rather than completing the pin re-insertion troubleshooting.

• Brand Name: PULSE GEN MODEL 1000
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18291430
• MDR Text Key: 330049344
• Report Number: 1644487-2023-01769
• 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: 02/21/2024

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: Health Professional
• Device Model Number: 1000
• Device Lot Number: 7675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 02/13/2024
• Supplement Dates FDA Received: 01/08/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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: 62 YR
• Patient Sex: Female