BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160668 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11791
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE PATIENT PRESENTED TO THE EMERGENCY ROOM. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING AND COIL IMPEDANCES. FURTHER INVESTIGATION REVEALED THAT THE SETSCREW WAS OUT OF POSITION, AND THE POCKET WAS REOPENED WHILE EVACUATING A POCKET HEMATOMA AT THE SAME TIME. THE LEAD WAS TESTED USING THE ANALYZER, AND AS ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS, THE LEAD WAS THEN RECONNECTED TO THE DEVICE, WHERE THE IMPEDANCES WERE HIGH ONCE MORE. THE DEVICE AND LEAD WERE DISCONNECTED AND RECONNECTED ONCE MORE, RESULTING IN NORMAL IMPEDANCE MEASUREMENTS, EVEN AFTER MULTIPLE MEASUREMENTS. THE DEVICE AND LEAD REMAIN 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
    641528 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R DVBB1D1 ICD