BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 3924261 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15172
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION AT 43.2 CM TO 43.5 CM FROM THE CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE. INITIAL REPORTER: RELIABILITY LABORATORY TECHNICIAN. ST. JUDE MEDICAL (B)(4) RELIABILITY LABORATORY.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399290 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1642T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1