BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 4833467 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07070
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: BOSTON SCIENTIFIC 0185 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP CHECK, OFFICE TESTING COULD PRODUCE A LITTLE NOISE ON THE CAN BUT NOTHING ON ANY OF THE OTHER LEADS NOR COULD THEY PRODUCE ANY OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EPISODES OF VENTRICULAR OVERSENSING, AND NOISE. RECOMMENDATION FOR ISOMETRICS MOVEMENT REPRODUCTION, INQUIRY ON LOCATION OF LEAD, AND ADJUSTMENT TO SENSITIVITY SETTINGS WAS MADE. THE RV LEAD REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380372 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR DTBA2D1 ICD