BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4163216 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12431
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FOUR DAYS POST IMPLANT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO AN ALERT. THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS LOW AND THRESHOLD HAD INCREASED. ECHOCARDIOGRAM SHOWED PERICARDIAL EFFUSION. THE LEAD WAS REPOSITIONED WITHOUT HEMODYNAMIC COMPROMISE. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643842 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R DVBB1D1 ICD