BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3152443 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06809
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 6947M55 IMPLANTABLE TACHY LEAD - (B)(6) 2012; 507645 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT PER THE NURSE THE THIRD LEAD WAS TAKING MORE ENERGY TO WORK. THE PATIENT STATED THAT THEY COULD FEEL THEIR HEART BEAT BEFORE AND NOW SINCE THE REPROGRAMMING THEY CANNOT FEEL IT ANYMORE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS CONFIRMED THAT THE LEFT VENTRICULAR (LV) LEAD HAD AN INCREASE IN TH RESHOLDS. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE.IT WAS NOTED THAT THE LEAD WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252729 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention D334TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB