BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3151786 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05619
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON A DEFIBRILLATION CONDUCTOR AND IT WAS NOT OBSTRUCTED, THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO, THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE GREATER THAN 3000 OHMS. SHORT VENTRICULAR-VENTRICULAR (V-V) INTERVALS WERE ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PHYSICIAN CUT THE LEAD POST EXPLANT TO LOOK FOR POSSIBLE WIRE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252798 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC