BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 5195124 · Received November 2, 2015

    Report

    Report Number
    2017865-2015-29751
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    October 9, 2015
    Report Date
    September 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION - PMA# SHOULD HAVE BEEN P030035 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION REVEALED MULTIPLE EPISODES OF VENTRICULAR NOISE REVERSIONS AND NOISE ON BOTH THE ATRIAL AND VENTRICULAR ELECTROGRAMS. ALL OTHER ELECTRICAL PARAMETERS WERE NORMAL. THE PHYSICIAN ELECTED TO ABANDON THE PULSE GENERATOR AND IMPLANTED A NEW SYSTEM ON THE RIGHT SIDE. THE PATIENT WAS DOING WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725905 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2212 3188779

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention (B)(4)