BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4313017 · Received December 10, 2014

    Report

    Report Number
    2649622-2014-14175
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH UNSTABLE, HIGH THRESHOLDS. THE LEAD WAS ALSO UNABLE TO DEFIBRILLATE THE PATIENT WITH AN ACCEPTABLE SAFETY MARGIN. THE PATIENT WAS EXTERNALLY SHOCKED DURING DIAGNOSTIC TESTING DUE TO THE INDUCED VENTRICULAR FIBRILLATION (VF) ARRHYTHMIA. THE RV LEAD WAS REMAINS IN USE WITH A NEW SUBQ LEAD WAS IMPLANTED AND CONNECTED TO SCV COIL PORT OF THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798637 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| L| R DDBB1D1 ICD, 5594-53 LEAD