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

Model Number 1000

Device Problem Mechanical Problem (1384)

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

Event Date 07/08/2020

Event Type  malfunction  

Event Description

It was reported that the patient can no longer feel autostimulation or magnet stimulation.The doctor interrogated the patient and it was noted that there were several months where all types of stimulation were not being recorded.When the doctor attempted to increase settings from 1.75-1.875 ma, he received error code 254.When diagnostics were attempted to be run, he received error code 254.It was confirmed that the advanced interrogation box was checked when using both systems.It was also noted that the doctor performed an extended data download and the events still did not show.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.At a previous appointment on (b)(6) 2020, the generator was in a normal state ("stim in offtime").On (b)(6) 2020, therapy run state was observed to be in stim inhibited when a magnet was not present.The manufacturer's device history records of the m1000 were reviewed.The generator passed final functional and quality specification prior to release.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient¿s device was showing error code 254 and output current is not available.He attempted to perform diagnostics and it loads 7-10% then error codes are seen.Patient reports that they do not feel stimulation with magnet or when the device turns on.No additional relevant information has been received to date.

Event Description

It was reported that the device has been shut off for a year but that patient feels like device vibrates and this has been going on for awhile.

Event Description

Information was received that the patient's device was interrogated and observed to be on.It was also noted that the patient is has been experiencing increased seizures which is likely due to the reed switch failure and the patient not receiving proper therapy.

• 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: 11149887
• MDR Text Key: 228239458
• Report Number: 1644487-2021-00056
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: 1000
• Device Lot Number: 204704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• 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: 33 YR
• Patient Sex: Female