BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954491 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02276
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACE/SENSE IMPEDANCE, OVERSENSING, NOISE AND WAS FRACTURED. IT HAS BEEN UNABLE TO DETERMINE IF THE PATIENT'S SHOCKS ARE APPROPRIATE. THE RV LEAD WAS INACTIVATED AND WAS LATER CAPPED AND WAS NOT REPLACED AS THE PATIENT NO LONGER REQUIRES THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59308 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR