BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY

    MDR report key: 3811323 · Received May 15, 2014

    Report

    Report Number
    2649622-2014-04830
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    December 9, 2012
    Report Date
    May 16, 2014
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE WITH THE FUNERAL HOME, PRIMARY PHYSICIAN AND CARDIOLOGIST OFFICE. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT PRODUCT: D314TRG, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH INFORMATION INDICATING THE PATIENT IS DECEASED. NO FURTHER INFORMATION WAS PROVIDED. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER AN UPGRADE TO A BI-VENTRICULAR ICD SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291141 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death 0157 LEAD, 4086 LEAD