BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 4163420 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12330
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD BECAME DISLODGED AND COULD NOT BE SECURED TO THE PATIENT'S ANATOMY. THE PROCEDURE TIME WAS LENGTHENED BY APPROXIMATELY TWO HOURS. THE LV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640264 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR