BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153191 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05863
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    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. THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. A D284DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).   (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSCHEDULED FOLLOW-UP THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A LEAD INTEGRITY ALERT (LIA) DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256039 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R