BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3864904 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07458
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE 419488 LEAD WAS RETURNED, ANALYZED AND REVEALED NO ANOMALIES WERE FOUND.

    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 AN IMPLANT ATTEMPT FOR SYSTEM UPGRADE, THE LEAD WAS UNSTABLE WITHIN THE TARGET VESSEL, DISLODGED, AND HAD DIAPHRAGMATIC PACING. THE PHYSICIAN DECIDED TO ATTEMPT ANOTHER LEAD AND WAS UNABLE TO FIND A SUITABLE PLACEMENT DUE TO DIAPHRAGMATIC PACING WITHIN THE TARGET VESSEL. AFTER SEVERAL REPOSITIONS AND DUE TO THE LACK OF ADDITIONAL TARGET VESSELS THE PHYSICIAN ELECTED TO NOT IMPLANT THE BI-VENTRICULAR LEAD AT THIS TIME. A DEFIBRILLATOR LEAD WAS IMPLANTED IN THE RV APEX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340535 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR