BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 2240506 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05415
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 3, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD COIL WAS FRACTURED AT 53 CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH. THE PROXIMAL INSULATION WAS DAMAGED AT 22.5 CM FROM THE CONNECTOR PIN.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PACEMAKER VIBRATION ON 07-05. THE VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD WAS TURNED OFF ON 07-07. ON 08/03 A FRACTURE WAS NOTED ON THE LEAD AT THE CLAVICLE AND THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 1999/52, (B)(4)