BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 21683353 · Received March 24, 2025

    Report

    Report Number
    1644487-2025-00326
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 26, 2025
    Report Date
    December 2, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THERE WAS NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE FOLLOWING TROUBLESHOOTING STEPS WERE TIRED: BATTERIES CHECK, EMI SOURCES MOVED AWAY, BATTERIES REPLACED, HARD RESET BOTH TABLET AND WAND, PLACEMENT OVER GENERATOR + ROTATED DEVICE 45 DEGREES. BUT DESPITE TROUBLESHOOTING THE DEVICE COULD NOT BE INTERROGATED.

    Description of Event or Problem · 0

    THE SUSPECT GENERATOR WAS RECEIVED, AND PRODUCT ANALYSIS IS UNDERWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AND THEIR DEVICE COULD NOT BE INTERROGATED. MULTIPLE WANDS AND TABLETS, WHICH ALL WORKED ON OTHER PATIENTS, WERE TRIED BUT THE INTERROGATION WAS STILL UNSUCCESSFUL. THE LAST KNOWN BATTERY STATUS WAS OK ON (B)(6) 2024. THE PHYSICIAN ASSISTANT IS QUESTIONING WHY THE DEVICE ONLY LASTED LESS THAN 3 YEARS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754276 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 205622 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male