BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 1223647 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03221
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE PACING CONFIGURATION WAS ADJUSTED TO BIPOLAR, BUT THAT DID NOT RESOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1