BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993787 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09126
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    February 17, 2012
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PRODUCT: D154AWG ICD IMPLANTED 2009-(B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 2.5 YEARS EARLIER, THE PATIENT EXPERIENCED THREE INAPPROPRIATE SHOCKS DUE TO THE RIGHT VENTRICULAR LEAD OVERSENSING T WAVES. THE LEAD WAS REPROGRAMMED AND REMAINED IN USE. WHEN THE DEVICE INDICATED END OF SERVICE (EOS), THE PHYSICIAN ELECTED TO REMOVE THE SYSTEM BECAUSE THE PATIENT'S EJECTION FRACTION (EF) HAD NORMALIZED AND THE PATIENT HAD NEVER RECEIVED APPROPRIATE THERAPY. WHEN THE RIGHT VENTRICULAR LEAD WAS EXTRACTED, THE PATIENT EXPERIENCE HYPOTENSION, AND A PERICARDIAL EFFUSION AND TAMPONADE WAS NOTED. PERICARDIOCENTESIS AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, THE DEVICE WAS EXPLANTED AND THE RIGHT ATRIAL LEAD WAS CAPPED, AND THE PATIENT WAS TAKEN FOR OPEN HEART SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470125 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| L| R 5076-52 LEAD