BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 4162989 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12530
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, ANALYZED AND THE DISTAL AND PROXIMAL CONDUCTORS OF THE LEAD WERE OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE LEAD WAS RETURNED WITH THE COMPETITOR GUIDEWIRE STUCK IN THE LEAD. IT IS LIKELY THAT THE GREEN COATING ON THE COMPETITOR GUIDEWIRE BECAME ENSNARED WITHIN THE DISTAL AND PROXIMAL CONDUCTORS CAUSING THE GUIDEWIRE TO BECOME STUCK. WHEN TRYING TO REMOVE THE GUIDEWIRE, THE LEAD WAS DAMAGED DURING THE ATTEMPTED IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE A COMPETITOR GUIDEWIRE BECAME STUCK INSIDE THE LEFT VENTRICULAR (LV) LEAD. 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
    640192 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR