BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153722 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06183
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 18, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. CONCOMITANT PRODUCTS: 419478 IMPLANTABLE PACING LEAD (B)(6) 2008; 507645 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) HAD TRIPPED FOR IMPEDANCE OUT OF RANGE ON THE HV (HIGH VOLTAGE) COILS OF THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THE LEAD¿S IMPEDANCES HAVE BEEN FLUCTUATING SINCE A RECENT DEVICE CHANGEOUT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE HIGH VOLTAGE CONNECTOR PINS WERE NOT FULLY INSERTED AT DEVICE CHANGE OUT CAUSING THE LEAD IMPEDANCE WARNINGS. THE IMPLANT WAS REVISED TO RECONNECT THE HIGH VOLTAGE PINS TO THE HEADER WITHOUT INCIDENT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254949 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB