BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3926441 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15266
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS WOUND WAS NOT HEALING, THE SYSTEM WAS EXPLANTED AND A NEW SYSTEM PLACED ON THE RIGHT SIDE AND THE POCKET WAS GLUED. AT FOLLOW UP THE GLUE HAD BEEN PICKED OFF. THE PHYSICIAN SUSPECTED THAT THE WOUND DID NOT HEAL BECAUSE THE PATIENT WAS PICKING AT IT. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404088 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention (B)(4)