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 09/06/2023

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 patient's device could not be interrogated with multiple programmers known to successfully interrogate other patients.Wired connection was unsuccessful and several other troubleshooting steps including programmer/wand resets, generator reset, and wand battery replacements were not successful, all producing a 'generator not found' error message.Patient reportedly cannot feel magnet or normal mode stimulation.Programming history was reviewed and no anomalies were seen.Data was not available for the timeframe relevant to the reported event.Quality engineering review of the event was completed.With the limited information available at this time no definitive cause was established.There are several potential factors like component failure or an open short condition that could have contributed to observed condition.Product analysis after the device return is the only way to determine the definite root cause of the event.Device history records were reviewed and the device passed all functional and quality testing prior to distribution.The physician was recommended to proceed with a battery replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient had a battery replacement.The explanted device has not been received to date.No other relevant information has been received to date.

Event Description

The device has been received into product analysis.No other relevant information has been received to date.

Event Description

Product analysis was completed and the device was found to be at end of service due to premature depletion caused by a component failure.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: 17844454
• MDR Text Key: 324601573
• Report Number: 1644487-2023-01406
• 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,Followup
• Report Date: 04/26/2024

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: 720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 01/03/2024; 04/02/2024
• Supplement Dates FDA Received: 12/19/2023; 01/26/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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: 35 YR
• Patient Sex: Female