BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992533 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09805
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. CONCOMITANT PRODUCT: D274TRK ICD IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD. ELECTROCARDIOGRAM (ECG) SHOWS NON-PHYSIOLOGIC SENSING IN THE RV WITH SEVERAL SHORT INTERVAL COUNTS (SIC) INTERROGATED ON THE RV LEAD. AN IMPEDANCE MEASUREMENT SHOWS HIGH IMPEDANCE FLUCTUATING IN THE PACE/SENSE PORTION OF THE LEAD. THE PACE/SENSE PORTION OF THE RV LEAD WAS FOUND TO HAVE FRACTURED. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. THE RV HIGH VOLTAGE COILS REMAIN IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A POCKET HEMATOMA THAT REQUIRED A POCKET EVACUATION. A FEW WEEKS LATER, THE PATIENT HAD ANOTHER POCKET HEMATOMA THAT REQUIRED INTRAVENOUS THERAPY OF VANCOMYCIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467424 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 5076-58 LEAD, 4193-88 LEAD