BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993178 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09445
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. ALTHOUGH THE LEAD LENGTH IS CORRECT, THE KINKED/BUCKLED INNER INSULATION INDICATES THE LEAD WAS STRETCHED SOMETIME DURING THE ATTEMPTED IMPLANT. AN INNER OR OUTER INSULATION BREACH WAS NOT OBSERVED. IT IS LIKELY THE BLOOD ON THE DISTAL CONDUCTOR ENTERED THROUGH THE CONNECTOR PIN. DESTRUCTIVE ANALYSIS WAS PERFORMED AND ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. NO OTHER ANOMALIES WERE OBSERVED ON THE RETURNED LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468844 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR