BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 4193306 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05550
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 16, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC, CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF THRESHOLD AND IMPEDANCE ANOMALIES WAS NOT CONFIRMED. ANALYSIS WAS NORMAL AND NO ANOMALY WAS FOUND EXCEPT NORMAL CRIMP MARKS AND J SHAPE. TWO TINES ON TINES SLEEVE WERE MISSING THAT WAS POSSIBLY DUE TO AN INTRODUCER OR ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD EXHIBITED THRESHOLD AND IMPEDANCE ANOMALIES. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30296 ISOFLEX S PERMANENT PACEMAKER ELECTRODE, NVN NVN ST. JUDE MEDICAL, INC, CRMD 1642T/52

    Patients

    Seq Age Sex Outcome Treatment
    1