BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 1955480 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00623
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 7, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN -EXCESSIVE FORCE WITH HER LEFT ARM- THE PATIENT COMPLAINED OF WORSENING SHORTNESS OF BREATH. DEVICE EVALUATION FOUND LEAD DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1156T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4)