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

Model Number 1000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/28/2024

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 that the new device was seen with a broken setscrew and surgeon was unable to insert the pin effectively.Surgeon used a different generator successfully.Device history records were reviewed and the device was seen to pass all functional and quality testing prior to distribution.The unused device has not been received to date.No other relevant information has been received to date.

Event Description

The device has been received into analysis.The original reporting physician's information and patient information has been received.No other relevant information has been received to date.

Event Description

Product analysis was approved on the generator.The device was observed as received prior to decontamination with the setscrew stuck in the septum.In addition, the as received condition of setscrew socket shows mechanical wear and is filled with septum debris.The septum shows damage on the underneath side suggesting that the setscrew was extracted up into the septum.The setscrew being extracted up into the septum may have been a contributing factor for the as received condition of the returned setscrew and septum.Other than the observed setscrew condition there were no performance, or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

• 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: 18961107
• MDR Text Key: 338380347
• Report Number: 1644487-2024-00333
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 05/31/2024

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: 853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/02/2024; Not provided
• Supplement Dates FDA Received: 04/26/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2023
• 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: 18 YR
• Patient Sex: Female