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

Model Number 1000

Device Problem Communication or Transmission Problem (2896)

Patient Problems Convulsion, Clonic (2222); No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2020

Event Type  malfunction  

Event Description

It was reported that a m1000 generator implanted in early (b)(6) 2020 was unable to be interrogated.By different programming systems in (b)(6) 2020.A company representative assisted in person and also was unable to interrogate the patient's device.It was noted that the patient was fairly skinny and that the generator was easily palpable with nothing atypical in placement that may impede interrogation.The patient reported no longer feeling stimulation.The internal data of the generator from previous visits was reviewed and no anomalies were identified.Impedance was within normal limits during implant and generator voltage and minimum generator voltage detected was as expected based on device age.There was no evidence of device reset.Review of the tablet/s logs during the attempts to communicate was also unable to determine the reason for failure to interrogate.The manufacturer's device history records for the 1000 generator were reviewed.The generator passed final functional and quality specifications prior to release.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that after a device reset of the generator was performed, the generator was able to be interrogated.The data from the interrogation after the reset was reviewed and no obvious issue to cause the failure to communicate was identified.Based on the number of normal mode stimulations total provided by the generator vs expected number, it was believed that the generator had likely been stimulating normally.It was noted that prior to the device reset, they had tried communicating with the generator with different programming systems on 2 different days without success.It was noted that the patient had had worsened seizures along with inability to perceive stimulation.No further relevant ifnromation has been received to date.

Event Description

More detailed data was reviewed from a follow-up appointment it was noted that there was no gaps in daily autostimulations since around time of implant, which indicates that the generator consistently provided stimulation even during the period of time where the generator couldn't be interrogated.No further relevant information has been received to date.

Event Description

The patient's treating medical professional believed that because the patient was feeling stimulation, was having worsening seizures and felt stimulation when the generator was restarted, the generator wasn¿t actually discharging even though it was recording discharges.He noted that he'd had no issues interrogating other patient's in the same room during the time period of the event and since.No further 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
• MDR Report Key: 11180892
• MDR Text Key: 228239753
• Report Number: 1644487-2021-00073
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2021

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: 03/18/2022
• Device Model Number: 1000
• Device Lot Number: 205258
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 03/30/2021; 05/07/2021; 06/17/2021
• Supplement Dates FDA Received: 02/19/2021; 04/09/2021; 06/01/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR