BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-STANIOR NUCLEAER

    MDR report key: 3923119 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14458
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED INAPPROPRIATE RATE DECREASE; THE DEVICE WAS PACING BELOW THE BASE RATE THE DEVICE WAS EXPLANTED AND REPLACED DURING LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401772 OMNI-STANIOR NUCLEAER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 184B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR