BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 5861065 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-09563
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: #ANALYSIS INFORMATION (B)(6) 2016 18:06:45. (B)(4), PRODUCT ID# 6935M55; THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT THE HELIX EXTENDS AND RETRACTS WITHIN SPECIFICATION, THE STYLET FULLY INSERTS IN LEAD, AND THE LEAD FULLY INSERTS IN INTRODUCER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INDICATED HAVING DIFFICULTY PLACING THE LEAD IN THE RV APEX. THE PHYSICIAN INDICATED IS WAS VERY HARD TO STEER THE LEAD BECAUSE THE INTERNAL LEAD LUMEN WAS OFF-CENTERED. THE LEAD WAS ALSO NOTED TO NOT STAY IN THE APEX AS IT HEADED TOWARD THE SEPTUM OR RETRACTED OUT OF THE RV. THE PHYSICIAN WAS NOTED TO HAVE PULLED BACK THE STYLET FROM THE TIP 5-7 CM. A LONGER LENGTH LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515713 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR