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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

It was reported that when trying to interrogate m1000 error code 254 was received.It noted that he current is not being delivered.Troubleshooting was performed as well as a hard reset and then low impedance was seen.The internal data was reviewed and it was determined that the patient was in a stim inhibited state during interrogation, indicating that the reed switch of the generator was closed even though a magnet was not present.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.Internal investigation into similar events was unable to determine a definitive root cause of reed switch failures.The primary root cause is believed to be reed switches sticking in the closed position after extended exposure to magnetic fields.The investigation also identified residual magnetic properties of the generator battery to be a potential contributor.However; testing performed during the investigation found the effect to be highly variable with each magnetic field exposure and any closure of the reed switch impacted by this phenomenon would likely be reversed by subsequent swiping of the patient magnet.Thus, the most likely contributor of the identified complaints is considered to be mechanical sticking of the reed switch blades.No further relevant information has been received to date.No known relevant surgical intervention has occurred 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'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

The generator was replaced and received for analysis.Patient was admitted for hospitalization as a result of the procedure with moderate severity.Analysis of the generator is underway but has not been completed to date.

Event Description

An update was received that the event has recovered / resolved.

Event Description

Product analysis for the generator was completed and approved.The reported allegations of ¿mechanical problem reed switch malfunction reed switch closed¿, and ¿device failure¿, were confirmed in the lab due to the reed switch being stuck closed.An interrogation and system diagnostic test (results <= 600 ohms) were performed at the pa test bench.The device was programmed to 1.00ma output, the bench oscilloscope showed no device output signal suggesting the reed switch is closed.The device output signal was not monitored for the 24-hr period due to the device having no output signal.A comprehensive automated electrical evaluation was performed but did not meet specification due to the suspected closed reed switch which inhibits the output.A comprehensive automated electrical evaluation was performed, and the device met specification.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.A comprehensive automated electrical evaluation was performed, and the device met specification.Other than the reed switch stuck closed condition, the device performed according to functional specifications.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14989526
• MDR Text Key: 302058662
• Report Number: 1644487-2022-00844
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2022

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 Expiration Date: 05/06/2023
• Device Model Number: 1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 08/24/2022; 09/29/2022
• Supplement Dates FDA Received: 08/22/2022; 09/16/2022; 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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: 67 YR
• Patient Sex: Female