BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 2983812 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01386
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 28, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING IN THE POCKET AREA. THE PATIENT DEVELOPED AN INFECTION. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87906 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4).