BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY PLUS DR RF

    MDR report key: 3920634 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14242
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 NOTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, ATRIAL LEAD INSERTION IN THE PULSE GENERATOR WAS VERY DIFFICULT. AFTER THE TIP WAS DIPPED IN SALINE SOLUTION, THE LEAD COULD BE INSERTED IN THE HEADER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 NOTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. THE PULSE GENERATOR EXHIBITED MULTIPLE EPISODES OF NOISE REVERSION CAUSING MODE SWITCH AND HIGH IMPEDANCES ON THE ATRIAL CHANNEL. X-RAY CONFIRMED THAT THE ATRIAL LEAD WAS NOT ALL THE WAY THROUGH IN THE HEADER. THE DEVICE WAS REPROGRAMMED TO VVI AND THE PATIENT WAS SCHEDULED FOR DEVICE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398191 ASSURITY PLUS DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention