BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 3861683 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07187
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT HAD EXTREMELY TORTUOUS ANATOMY FROM THE SUBCLAVIAN VEIN DOWN TO THE HEART, IN WHICH THE PHYSICIAN EXPRESSED GREAT DIFFICULTY PASSING THE LEAD DOWN TO THE HEART. ONCE THE LEFT VENTRICULAR (LV) LEAD WAS IN POSITION, AND THE CATHETER WAS SLIT, THE PHYSICIAN NOTED THAT THE STYLET WITHIN THE LEAD COULD NOT BE RETRACTED. THE PHYSICIAN DECIDED TO CUT THE STYLET, LEAVING THE REMAINS WITHIN THE LV LEAD AND MONITOR THE PATIENT CLOSELY. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342045 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR