BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2791684 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14551
    Event Type
    Injury
    Date Received
    October 15, 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
    NY, 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 THE IMPEDANCE MEASUREMENTS WERE HIGH ON THE SUPERIOR VENA CAVA COIL (SVC) OF THE LEAD. THE PHYSICIAN SUSPECTED A SET SCREW ISSUE ON THE DEVICE. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. DURING THE PROCEDURE, THE LEAD IMPEDANCE WAS CHECKED THROUGH THE ANALYZER AND THE NEW DEVICE AND THE LEAD IMPEDANCE MEASUREMENTS REMAINED HIGH. IT WAS DETERMINED THERE WAS A FRACTURE OF THE SVC COIL ON THE LEAD. THE SVC COIL WAS PROGRAMMED OFF AND THE LEAD REMAINS IMPLANTED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB