BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3990057 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08838
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT MEDICAL PRODUCTS: 694958 IMPLANTABLE TACHY LEAD, (B)(6) 2006; 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY WERE IN ATRIAL FIBRILLATION (AF) ALL THE TIME, ONE OF THEIR PACING LEADS WAS NOT WORKING, AND THEY WENT IN TO SURGERY FOR A DEFECTIVE LEAD. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE AT MAXIMUM OUTPUT. THE LV LEAD WAS CAPPED 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
    462882 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R DTBA1D1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR