BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 4833998 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06852
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS SUCCESSFULLY IMPLANTED BUT THEN DISLODGED. ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE AND THE ORIGINAL LEAD WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378535 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429878

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR