BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3153706 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06179
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    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. PRODUCT: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2013; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOON AFTER THE LEFT VENTRICULAR LEAD WAS IMPLANTED IT DISLODGED. REPOSITIONING OF THE LEAD WAS ATTEMPTED, BUT DURING THE REPOSITIONING CORONARY SINUS PERFORATION OCCURRED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254674 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD