BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153055 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05793
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. IT WAS FURTHER NOTED THAT THE DEFIBRILLATION SUPERIOR VENA CAVA (SVC) CONDUCTOR WAS KINKED, BUCKLED, PULLED, STRETCHED AND OVERSTRESSED. THERE WAS BLOOD (NOT OBSTRUCTED) ON THE PROXIMAL AND DISTAL CONDUCTORS, AND BLOOD COVERING THE DISTAL END. PERFORMANCE DATA WAS COLLECTED FROM THE LEAD AND ANALYZED. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON 2013-02-18. THE PROGRAMMER DATA SHOWED AN ALERT FOR SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE GREATER THAN 200 OHMS ON 2013-02-28. CONCOMITANT PRODUCTS: D334DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2013; 4076, IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK AFTER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE, THERE WAS AN ALERT FOR RIGHT VENTRICULAR (RV) LEAD IMPEDANCE OUT OF RANGE. THE POCKET WAS RE-OPENED, AND IT WAS FOUND THAT THE CHRONIC SUPERIOR VENA CAVA (SVC) COIL WAS NOT COMPLETELY SECURED IN THE HEADER OF THE ICD. UPON RECONNECTING THE DEVICE, THE COIL IMPEDANCE JUMPED TO A HIGH MEASUREMENT. BLOOD WAS REPORTED IN THE HEADER OF THE DEVICE. IT WAS ALSO NOTED THAT THERE MAY BE A SET SCREW ISSUE. THE ICD WAS EXPLANTED AND REPLACED; HOWEVER, THE RV LEAD EXHIBITED INTERMITTENT HIGH IMPEDANCE ON THE HIGH VOLTAGE (HV) COIL IMPEDANCE. DETECTIONS WERE TURNED OFF ON THE LEAD, AND A FEW DAYS LATER, THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256173 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R