BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2813040 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15980
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS BEING CHECKED FOR CLEARANCE FOR BACK SURGERY, THE IMPLANT SITE WAS FOUND TO BE RED AND WARM. MEDICINE WAS ADMINISTERED. THE PATIENT THEN PRESENTED TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED DUE TO POTENTIAL HEMATOMA AND INFECTION. EXPLORATORY SURGERY WAS PERFORMED AT THE IMPLANT SITE, CULTURES WERE TAKEN AND THE DEVICE WAS REMOVED. IT WAS THEN NOTED THAT THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY FOR WOUND CARE. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE DEVICE WAS REMOVED AND THE LEAD DISPOSITION IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R