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

Model Number 1000

Device Problems Failure to Interrogate (1332); No Apparent Adverse Event (3189)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported the patient's device was implanted with no issues.However two weeks later high impedance was seen and the patient was referred back to surgery.During surgery to check the header connection, the device was found to be unable to communicate, therefore it was replaced.The lead remained implanted.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.Mfr report # 1644487-2023-01492 captures the failure to program on the suspected generator.Mfr report # 1644487-2023-01493 captures the high impedance on the suspect lead.

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

Product analysis was completed on the returned generator.

Event Description

The suspect device was received into product analysis to undergo testing.Testing has yet to be completed to date.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: 17953433
• MDR Text Key: 326260566
• Report Number: 1644487-2023-01492
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

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: Lay User/Patient
• Device Model Number: 1000
• Device Lot Number: 206020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 03/04/2024
• Supplement Dates FDA Received: 01/25/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2023
• 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