BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3860943 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06811
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE A SIMILAR 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 AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POCKET WAS REVISED DUE TO EROSION OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). DURING THE PROCEDURE THE PHYSICIAN TESTED THE LEADS AND THE IMPEDANCE ON THE RIGHT VENTRICLE (RV) AND SUPERIOR VENA CAVA (SVC) COILS OF THE RIGHT VENTRICULAR LEAD WERE HIGH. THE LEAD WAS EXPLANTED AND REPLACED AND THE DEVICE WAS PLACED IN A NEW POCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342173 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R D364TRG ICD