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

Model Number 1000

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Defective Component (2292)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that during a battery replacement procedure it was noted that the new generator could not be interrogated.Troubleshooting of electro magnetic interference reduction, and repositioning of interrogation wand was performed which did not resolve the problem.A back-up generator was then implanted with no issue.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.

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 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

Suspect device has been received and is undergoing product analysis.Data from the programming system used when trying to interrogate the generator was also received.The data showed several attempts to communicate with an unknown ipg, all of which returned with error code 128 (timeout).This is likely when the generator was attempted to be interrogate at a later date, after the date of surgery.No other relevant information has been received to date.

Event Description

Product analysis completed testing of the returned device.Evaluation of the device revealed that the device prematurely depleted causing it to reach end of service.The device was unable to be interrogated as a result.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: 18267656
• MDR Text Key: 329736146
• Report Number: 1644487-2023-01721
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

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: 7637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/15/2024; 02/14/2024
• Supplement Dates FDA Received: 02/07/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• 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: 16 YR
• Patient Sex: Female