BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR

    MDR report key: 7857989 · Received September 7, 2018

    Report

    Report Number
    2938836-2018-10443
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    July 13, 2018
    Report Date
    November 14, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    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

    CORRECTION: THE PREVIOUSLY REPORTED G5 PMA/510(K) # OF "BLANK" WAS INCORRECT. THE CORRECT RESPONSE IS P880086.

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE DEVICE REVEALED THAT DEVICE WAS AT EOL WHEN RECEIVED. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND THE BATTERY DEPLETION WHILE IMPLANTED IN THE PATIENT TO BE NORMAL BASED ON DEVICE USAGE. POST DEVICE EXPLANT, HIGH CURRENT AND ACCELERATED BATTERY DEPLETION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED TO THE HOSPITAL ELECTIVE REPLACEMENT INDICATOR WAS OBSERVED ON THE DEVICE. UPON DEVICE INTERROGATION AND REVIEW OF THE DEVICE SETTINGS, THE DEVICE SHOWED PREMATURE BATTERY DEPLETION. DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. PATIENT WAS STABLE WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696431 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PM2112 3490772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention