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 02/14/2024

Event Type  malfunction  

Event Description

It was reported that during a clinic visit error code 254 was presented after an interrogation.There were no issues with interrogating the device and changing the settings, but no matter how low the settings were adjusted the "low output current" message was observed.Troubleshooting was performed in the form of: attempting a tablet and wand reboot, confirming the wand was connected to the tablet, wired connection was used and the batteries were all confirmed, quickly passing the magnet over the generator site was completed.They had exited the session multiple times and the issue persists.The programmer was able to interrogate another patient okay.When they interrogated the patient at 0 ma, they were able to get an impedance ~3000 ohms.However when they performed this interrogation again they kept getting an identical impedance value.A generator reset was performed in which low impedance was identified.The patient has been referred for surgery.The generator's stored data was able to be reviewed in which, an issue regarding the reed switch was identified.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.No known relevant surgical intervention has occurred 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'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 later reported that the generator was replaced.All impedance were okay after the battery replacement.The explanted device has not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

It was reported that the suspect product has been returned to the manufacturer.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: 18867147
• MDR Text Key: 337527874
• Report Number: 1644487-2024-00271
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/20/2024

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: 7582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: Not provided; 04/25/2024
• Supplement Dates FDA Received: 04/19/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2023
• 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 Sex: Male