BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY PACEMAKER, DR, MRI RESTRICTED

    MDR report key: 13793797 · Received March 17, 2022

    Report

    Report Number
    2017865-2022-04997
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    January 24, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 - PREVIOUSLY NOTED MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UDI SHOULD BE PM2272, 5030208, (B)(6), 30 SEP 2019, AND (B)(4), RESPECTIVELY. G3 - PREVIOUSLY NOTED PMA SHOULD BE P140033. H4 - PREVIOUSLY NOTED DEVICE MANUFACTURE DATE SHOULD BE 13 MAR 2018.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED. INTERROGATION OF THE DEVICE REVEALED THE DEVICE WAS AT END OF LIFE (EOL). ANALYSIS OF THE DEVICE IMAGE AND A LONGEVITY CALCULATION WAS PERFORMED AND FOUND THE BATTERY DEPLETION WAS NORMAL BASED ON THE DEVICE USAGE. BASED ON THIS INFORMATION, THERE WAS NO EVIDENCE OF PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246333 ENDURITY PACEMAKER, DR, MRI RESTRICTED IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000058450 05414734509589
    2301302 ENDURITY PACEMAKER, DR, MRI RESTRICTED IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000058450 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention