BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964913 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02148
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4): LEAD REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE AND SHORT INTERVALS COUNTS, WHICH COULD INDICATE OVERSENSING. THE RV (RIGHT VENTRICULAR) LEAD PACE/SENSE PORTION WAS SWAPPED TO THE LV (LEFT VENTRICULAR) PORT, AND THE LEAD REMAINS 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
    68018 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R