BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR

    MDR report key: 4870080 · Received June 25, 2015

    Report

    Report Number
    2017865-2015-26330
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 13, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE CORRECT THIS REPORT 2017865-2015-26330. THIS EVENT WAS PREVIOUSLY REPORTED ON MDR 2017865-2015-26822 UNDER THE CORRECT SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    UDI (DI): UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411780 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention