BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 1896529 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04862
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 PRODUCT WOULD NOT COME OFF STANDBY. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF 10 MINUTES. THERE WAS NO HARM TO THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED CAPTURE ISSUES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention