BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1896556 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04956
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR CAPTURE THRESHOLD WAS GREATER THAN 7.5 V, 1.5 MS. EXIT BLOCK WAS SUSPECTED. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention