BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2953107 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00923
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE PATIENT WAS SEEN WITH PERICARDIAL EFFUSION AND IT WAS SUSPECTED THE LEADS PERFORATED THE WALLS OF THE CARDIAC CHAMBERS. THE PATIENT HAD TAMPONADE AND A PLEURAL EFFUSION. THE PERICARDIAL EFFUSION WAS DRAINED AND A X-RAY AND COMPUTED TOMOGRAPHY (CT) SCAN WERE PERFORMED. THE LEADS WERE PLANNED TO BE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57224 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD