BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX P

    MDR report key: 2905159 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00605
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION. THE RIGHT VENTRICULAR LEAD EXHIBITED INCREASED THRESHOLDS AND LOW IMPEDANCE DUE TO A BROKEN INSULATION. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12031 ISOFLEX P PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1648T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR