BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2954706 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02404
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE PATIENT DEVELOPED AN INFECTION AND THEIR DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58813 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization 2088TC COMPETITOR IMPLANTABLE PACING LEAD