BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3993438 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09320
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 MEDICAL PRODUCTS: 694758 LEAD, IMPLANTED (B)(6) 2010; 5076-45 LEAD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED FOR EARLY BATTERY DEPLETION, POSSIBLY DUE TO A RISING AND ELEVATED LEFT VENTRICULAR (LV) LEAD THRESHOLD. FAILURE TO SUSTAIN CAPTURE WAS ALSO OBSERVED ON THE LV LEAD WHICH HAD BEEN REPROGRAMMED ON MORE THAN ONE OCCASION TO OPTIMIZE ICD BATTERY LIFE. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471112 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention D274TRK ICD