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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Output below Specifications (3004); Physical Resistance/Sticking (4012)

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

Event Date 06/01/2023

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 livanovas 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 multiple interrogations showed low output current with the patients generator.It was noted that the provider thinks the implant is malfunctioning.Patient was referred for battery replacement additional information was received noting an error code was seen during a follow up interrogation.Troubleshooting steps resolved the issue and the patient was successfully interrogated showing normal impedance and low output.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received noting that the patient underwent a battery replacement which resolved the low output current issue.Explanted device was received by the manufacturer and is undergoing product analysis.No other relevant information has been received to date.

Event Description

Additional information was received noting that the report of low output current caused the patient to not receive a meaningful reduction in seizures with vns product analysis was completed for the returned device.No other relevant information has been received to date.

Event Description

Internal generator data was received.As magnet stimulation inhibition was observed in conjunction with low current output observed by the physician, and the error code 254 reported by the physician and confirmed by product analysis, it can be concluded that the root cause of the event is most likely a reed switch failure due to the switch getting stuck closed.No other relevant information has been received to date.

Event Description

Additional information was received noting the correct available date range for the internal generator data.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: 17699814
• MDR Text Key: 322852902
• Report Number: 1644487-2023-01253
• 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,Followup
• Report Date: 05/14/2024

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: 205994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/20/2023; 10/31/2023; 12/22/2023; 02/07/2024; 05/01/2024
• Supplement Dates FDA Received: 10/11/2023; 12/01/2023; 01/10/2024; 02/27/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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: 25 YR
• Patient Sex: Female