BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 4832545 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07529
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AN ATTEMPTED IMPLANT, THE LEADS COULD NOT REACH THE TARGET POSITION AND BE FIXED ADEQUATELY DUE TO PATIENT ANATOMY. IT WAS NOTED THAT THE LEADS REPEATEDLY DISLODGED FROM THE TARGET VESSEL. THE PHYSICIAN ELECTED TO GIVE UP THE IMPLANTATION OF THE LEFT VENTRICULAR (LV) LEAD AND PULLED OUT THE RIGHT ATRIAL (RA) LEAD. THE PHYSICIAN IMPLANTED A SINGLE CHAMBER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380574 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR