BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954619 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02363
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 4, 2009
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT PRODUCT: 1688TC COMPETITOR IMPLANTABLE PACING LEAD 2008 (B)(6); CONCOMITANT PRODUCT: 4193 IMPLANTABLE PACING LEAD 2004 (B)(6); CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE TACHY LEAD 2004 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) WAS NOTED WITH THE RIGHT VENTRICULAR (RV) LEAD. THEREFORE THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED WITH A NEW PACE/SENSE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59759 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB