BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2954409 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02234
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    October 15, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ONE MONTH POST-OP THE THRESHOLDS ON THE RIGHT VENTRICULAR LEAD WERE ELEVATED. IT WAS BELIEVED THAT THE LEAD PULLED AWAY FROM THE CARDIAC TISSUE AND WAS DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58072 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 4296 IMPLANTABLE PACING LEAD