BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790743 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15059
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 THE PACE/SENSE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS HIGH DUE TO A LOOSE SETSCREW ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE POCKET WAS OPENED AND THE PHYSICIAN TUGGED GENTLY ON THE LEAD AND IT CAME OUT OF THE PORT. THE LEAD WAS CHECKED WITH THE ANALYZER AND PLACED BACK INTO THE PORT WITHOUT DIFFICULTY. THE LEAD AND DEVICE REMAIN IN USE. NO 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD