BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2951966 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00327
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    February 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE. THE PACE/SENSE PORTION OF THE LEAD HAD NORMAL IMPEDANCE, NO CLINICAL PERFORMANCE ISSUES WERE NOTED, AND NO ACTION IS PLANNED. THE LEAD REMAINS IN USE. THE PATIENT WAS A PARTICIPANT 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
    56780 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE DEFIBRILLATOR