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

Model Number 1000

Device Problems Premature Discharge of Battery (1057); Defective Component (2292)

Patient Problems Extreme Exhaustion (1843); Convulsion, Clonic (2222)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

It was reported that the patient has been referred for a replacement due to having a dead battery.The physician believes that the device depleted quickly and the patient is now experiencing an increase in seizures.They attempted to interrogate the device with no success.The patient had an x-ray perform to determine the location of the generator to ensure the wand was directly over it when interrogating but they were still unable to interrogate the device.No known 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

Additional information received noting that the patient has a decreased quality of life, increased seizures and increased amount of sleep.The patient then underwent a battery replacement.The explanted generator has not been received by product analysis to date.

Event Description

Additional information received noting that the cause of the increased seizures was related to other factors and the increase was back to pre-vns baseline levels.

Event Description

The explanted generator was received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator.The pulse generator would not communicate when received and tested in the livanova product analysis lab.It was also determined that the battery voltage indicated eos (end of service) =yes and that the therapy application was not running.Based on the function analysis the microprocessor (a1) from the dut pcba appears to be the cause for the increased current consumption of the pulse generator and may have been the contributing factor for the reported allegations of ¿premature end of life (eol)¿, ¿failure to program¿, and ¿device failure¿.The cause for the microprocessor (a1) increase in leakage current was not determined.Further assessment noted that the cause of this event could still not be determined for certainty.Of possible root cause identified, the most likely causes are incidental in-process esd, with several sub-causes such as transient discharge or sticking pogo pin from the m1000 solder fixture for battery attach were examined.Risk calculation were noted to be performed, and was found that the overall risk level associated with this event is low.

• 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: 17097599
• MDR Text Key: 316857568
• Report Number: 1644487-2023-00733
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2024
• Device Model Number: 1000
• Device Lot Number: 7141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 07/12/2023; 08/30/2023; 11/09/2023
• Supplement Dates FDA Received: 07/07/2023; 08/04/2023; 09/21/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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 Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male