BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2781766 · Received October 11, 2012

    Report

    Report Number
    2649622-2012-12904
    Event Type
    Injury
    Date Received
    October 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE LEFT VENTRICULAR (LV) LEAD HAD INCREASING AND HIGH IMPEDANCE AND TRIGGERED A LEAD WARNING. IT WAS ALSO REPORTED THAT THERE WAS LOSS OF CAPTURE NOTED ON THE LV LEAD. THE LV LEAD WAS PROGRAMMED OFF AND THE LV LEAD REMAINS IMPLANTED. THE LEAD ALERT WAS ALSO PROGRAMMED OFF. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO THE RIGHT VENTRICULAR (RV) LEAD HAVING OVERSENSING, VARYING AND HIGH IMPEDANCE VALUES DUE TO A RV LEAD FRACTURE. NO FURTHER PATIENT COMPLICATIONS WERE 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 80 YR Hospitalization| L| R 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB