BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY

    MDR report key: 3133469 · Received May 29, 2013

    Report

    Report Number
    2649622-2013-05446
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    August 12, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    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. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED NOTING THE PATIENT WAS 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); 407645 IMPLANTABLE PACING LEAD IMPLANTED: 2007 (B)(6); 694965 IMPLANTABLE TACHY LEAD IMPLANTED: 2007 (B)(6).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A MORTUARY WITH NO ADDITIONAL PATIENT INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER DEVICE AND LEFT VENTRICULAR LEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234466 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death