BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 6450850 · Received March 31, 2017

    Report

    Report Number
    2017865-2017-01973
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    February 21, 2017
    Report Date
    September 30, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE; THE REPORTED FIELD EVENT OF BACKUP OPERATION WAS CONFIRMED IN THE LABORATORY AND WAS FOUND TO BE DUE TO THE BATTERY VOLTAGE BEING AT EOL LEVEL. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND LOW IMPEDANCE WAS OBSERVED ON THE BATTERY WHICH WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE LOW BATTERY IMPEDANCE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510(K) # SHOULD HAVE BEEN - P880086 - RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A BEEPING SOUND. UPON INTERROGATION IT WAS NOTED THAT THE DEVICE AS IN BACKUP VVI. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233179 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2212 4163739

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention