BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954639 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02346
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCT: LEAD-MEDT IMPLANTABLE PACING LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE LEAD SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE LEAD CONDUCTOR WAS FRACTURED AND THE DEFIBRILLATION SUPERIOR VENA CAVA EXPOSED COIL WAS FLEXED/PULLED/STRETCHED/OVERSTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ISSUE. IT WAS ALSO REPORTED THAT UNDER FLURO IT WAS CLEAR THAT THE PROXIMAL LEAD COIL HAD BEEN DAMAGED. IT WAS FURTHER REPORTED THAT DURING ONE OF THE ATRIAL LEAD REPLACEMENTS THE PROXIMAL COIL MAY HAVE BEEN DAMAGED BY THE SELDINGER NEEDLE DURING VENOUS ACCESS. THE DEVICE AND LEADS WERE REMOVED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58371 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB