BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2811230 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15845
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE WEEKLY HIGH VOLTAGE LEAD IMPEDANCE TREND DATA SHOWED AN IMPEDANCE DECREASE FOR MAXIMUM AND MINIMUM DEFIB IMPEDANCE EQUAL TO 29 TO 19 OHMS MINIMUM BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM DUE TO REMOTE TRANSMISSION ALERT FOR LOW IMPEDANCE ON THE SCV COIL OF THE RIGHT VENTRICULAR LEAD. BECAUSE OF THE PATIENT'S CURRENT CONDITION AND DO NOT RESUSCITATE ORDER, IT WAS DECIDED TO REPROGRAM THE DEVICE TO TURN OFF THE LEAD. 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 REPORTED THAT THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM DUE TO REMOTE TRANSMISSION ALERT FOR LOW IMPEDANCE ON THESCV COIL OF THE RIGHT VENTRICULAR LEAD. BECAUSE OF THE PATIENT'S CURRENT CONDITION AND DO NOT RESUSCITATE ORDER, IT WAS DECIDED TOREPROGRAM THE DEVICE TO TURN OFF THE LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THISEVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD