BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3925641 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-14833
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED TO HAVE AN ALLERGIC RESPONSE TO THE IMPLANTED SYSTEM, BUT THE ALLERGY TESTS WERE NEGATIVE. THE POCKET WAS SLOWLY HEALING AND THE PHYSICIAN SUSPECTED THE PATIENT WAS PICKING AT THE GLUE THAT WAS USED TO SEAL THE IMPLANT SITE. THE PHYSICIAN ELECTED TO EXPLANT THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404240 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 7063309, (B)(4)