BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN STARFIX

    MDR report key: 3133155 · Received May 29, 2013

    Report

    Report Number
    2649622-2013-05441
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    May 29, 2012
    Report Date
    September 6, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4). CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2012 (B)(6); 5076-52 IMPLANTABLE PACING LEAD IMPLANTED: 2012 (B)(6); 693565 IMPLANTABLE TACHY LEAD IMPLANTED: 2012 (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE MONTH AFTER DEVICE, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235322 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death