BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810440 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15723
    Event Type
    Injury
    Date Received
    October 31, 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
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE AN ALERT TRIGGERED AND THAT THE RV LEAD WAS POSSIBLY FRACTURED AND THAT THE SUPERIOR VENA CAVA (SVC) COIL WAS INACTIVATED.

    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 LEAD WAS NOT RETURNED TO THE MANUFACTURER, HOWEVER, ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT, THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, AND THE IMPEDANCE TREND ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS VARIABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. IT WAS NOTED THAT THE IMPEDANCE WAS VARYING AND NOW IS CONSISTENTLY HIGH. THE PHYSICIAN PERFORMED A NON INVASIVE PROGRAMMED STIMULATION (NIPS) STUDY ON THE PATIENT AND THE RV LEAD WAS DETERMINED TO BE FUNCTIONING NORMALLY. THE RV LEAD REMAINS 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD