BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN STARFIX

    MDR report key: 2802068 · Received October 23, 2012

    Report

    Report Number
    2649622-2012-15612
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    January 8, 2009
    Report Date
    December 3, 2012
    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 EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. IT WAS FURTHER NOTED THAT THERE WAS BLOOD ON THE CONDUCTOR (NOT OBSTRUCTED), THE CONDUCTOR WAS DISTORTED, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD