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

Model Number	1000
Medical Device Problem Codes	False Alarm (1013); Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the physician, that the patient was seen in office earlier and device was showing a low output current error message telling her to reduce settings.Per the physician, pulse width and output current were lowered from 2ma to 1.75ma however did not resolve.The lead impedance was within normal limits and multiple interrogations/system diagnostics had been performed.It was also reported by the physician the following day that the message ¿current possibly not delivered¿ would appear upon interrogation or programming.The physician indicated that they were confident impedance was within normal limits and the output current delivered was the only issue.Follow-up with the physician after informing her of the data review that did not show any system diagnostics being performed, the patient was brought back into clinic.The physician performed an advanced interrogation so that system diagnostics could be performed comparing the new programmed output current.She indicated that results were all within normal limits with no error message.The physician indicated that they would be programming the patient back to their previous settings and would report any other issues related to this if they occurred.No additional relevant information has been received to date.
Event or Problem Description
The patient was seen at a later dat and low output current continues to be was observed.Diagnostics could not be performed.Patient was at 2.0ma and was decreased to 1.875ma.Generator accepted changes.Magnet would not be detected.Generator was interrogated again.No alerts and diagnostics were performed.No issues observed.Magnet swipe was registered.Troubleshooting was performed at an additional patient visit.Generator was programmed off and then back on.Low output current continued to be observed.System and magnet diagnostics were attempted, but could not be completed.Generator reset was performed and successful.Settings were noted to be able to be applied.System diagnostics was performed and subsequently low impedance was observed.The low impedance following generator reset likely confirms the reed switch failure.Internal generator data was reviewed and it was determined that the patient was in a stim inhibited state since (b)(6) 2020, indicating that the reed switch of the generator was closed even though a magnet was not present.It was also previously observed that error code 254 was reported when attempting to run system diagnostics, which is associated with reed switch closure/failure on m1000 generators.The manufacturer's device history records of the m1000 were reviewed.The generator passed final functional and quality specification prior to release.Patient was referred for xrays to confirm no lead issues were occurring.No known surgery has occurred to date.No additional relevant information has been received.
Event or Problem Description
Patient had a generator replacement.The explanted generator has not been received to date.No additional relevant information has been received.
Event or Problem Description
The explanted generator was received.Generator analysis was performed.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring demonstrate the appropriate magnet current for the programmed settings.Proper reed switch operation and detection of the reed switch is demonstrated by magnet activations during 24-hour monitoring.The resumption of pulsing after suppressing pulses during 24-hour monitoring demonstrated that the reed switch did not stick closed after applying the magnet for 20 minutes.Comprehensive automated electrical evaluation showed that the device performed according to functional specifications.

• Brand Name: PULSE GEN MODEL 1000
• Common Device Name: 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: 11784902
• Report Number: 1644487-2021-00612
• Device Sequence Number: 3201937
• Product Code: LYJ
• UDI-Device Identifier: 05425025750443
• UDI-Public: 05425025750443
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/22/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/02/2021
• Device Model Number: 1000
• Device Lot Number: 205136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 11/18/2021; 02/02/2022; 02/25/2022
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 12/15/2021; 02/24/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female