BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISOFLEX LEAD

    MDR report key: 3080536 · Received April 26, 2013

    Report

    Report Number
    2017865-2013-01721
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    August 31, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED POCKET EROSION AND DECEASED FROM SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181126 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)