BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3923496 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14766
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 10, 2009
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE INITIAL IMPLANT, THE PATIENT MOVED THEIR LEFT ARM AND EXPERIENCED COMPLETE HEART BLOCK. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED. AN ATTEMPT TO REPOSITION THE LEAD WAS UNSUCCESSFUL, AND THE LEAD WAS CAPPED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399659 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention