BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812864 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16702
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE HELIX/LOBE WAS DISTORTED/BENT AND THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED.) THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED TO BE ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD HELIX WOULD NOT DEPLOY COMPLETELY AFTER MULTIPLE ATTEMPTS. IT WAS NOTED THAT THERE WAS "VERY TIGHT ANATOMY AND IT WAS DIFFICULT TO PLACE THE LEAD". THE ATTEMPTED RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other