BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790614 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14754
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MPRI
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    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 RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE LEAD IMPEDANCE WAS SLOWLY TRENDING UP, THEN SPIKED AND TRENDED BACK DOWN AGAIN. DUE TO THE JUMP IN OPTIVOL IT WAS DETERMINED THAT THERE WAS NO LEAD ISSUE AND THAT THE PATIENT WAS SUSPECTED TO BE DEHYDRATED. NO CHANGES HAVE BEEN MADE AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER CLARIFIED THAT IT WAS THE RV SUPERIOR VENA CAVA (SVC) IMPEDANCE THAT WAS HIGH SHORTLY AFTER IMPLANT; IT WAS TURNED OFF AT THAT TIME. SVC WAS TURNED BACK ON RECENTLY AND IT WAS AGAIN INTERMITTENTLY HIGH AND THE HIGH VOLTAGE B (HVB) IMPEDANCE MEASURED HIGH ONCE. THE NURSE AND MEDICAL EQUIPMENT COMPANY REPRESENTATIVE DISCUSSED HOW LEAD IMPEDANCES WERE MEASURED AND THE LEAD HAS EXPECTED OPERATION. SVC WAS TURNED OFF AGAIN, DEFIBRILLATION TESTING WAS PERFORMED SUCCESSFULLY, AND THE LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R D314VRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB