BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN STARFIX

    MDR report key: 3233648 · Received July 18, 2013

    Report

    Report Number
    2649622-2013-08220
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    January 28, 2013
    Report Date
    June 21, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPT(S) FOR ADDITIONAL INFORMATION WITH THE FUNERAL HOME AND PHYSICIAN WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCTS: PRODUCT ID D224TRK IMPLANTED: (B)(6) 2012; PRODUCT ID 693558 IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS REPORTED AS DECEASED DURING A SEARCH OF THE MANUFACTURE DATABASE. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE ICD. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336002 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death