BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENCY SR+

    MDR report key: 3802518 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13753
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PULSE GENERATOR EXHIBITED A SUSPECTED MALFUNCTION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281623 REGENCY SR+ IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 2400L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention (B)(4)