BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951814 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00225
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON THE DEFIBRILLATION, DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER TUBING OVERLAY HAS COSMETIC ENVIRONMENTAL STRESS CRACKING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, THE PHYSICIAN NOTICED HIGH IMPEDANCES AND A LARGE NUMBER OF SENSING INTEGRITY COUNTER (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED BY THE PHYSICIAN THAT THE PATIENT HAD LOST BODYWEIGHT IN THE PAST YEARS AND IT WAS NOTICEABLE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSITION (POCKET) IN THE CHEST VARIED OVER TIME. THEREFORE WHERE THE LEAD ENTERS THE SUBCLAVIAN POSSIBLY RESULTED IN SOME STRESS FOR THE RV LEAD. THE DEVICE REMAINS IN USE AND THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57589 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR