BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922757 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13071
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    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 WHERE IT WAS DISCOVERED THAT THE EXPOSED DEFIBRILLATION COIL CONDUCTOR WAS SEVERELY DISTORTED WHICH IS SUSPECTED TO HAVE OCCURRED DURING THE IMPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN NOTED THAT THE 6947 LEAD COIL WAS SEPARATED AT THE PROXIMAL END OF THE RV COIL. UPON FURTHER INSPECTION BY THE PHYSICIAN IT WAS NOTED THAT THE SEPARATION WAS THROUGHOUT. A 6935 LEAD WAS PLACED INSTEAD AND PHYSICIAN FELT THE MOVEMENT WAS SNUG THROUGH THE INTRODUCER. THE 6935 WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN NOTED THAT THE 6947 LEAD COIL WAS SEPARATED AT THE PROXIMAL END OF THE RV COIL. UPON FURTHER INSPECTION BY THE PHYSICIAN IT WAS NOTED THAT THE SEPARATION WAS THROUGHOUT. A 6935 LEAD WAS PLACED INSTEAD AND PHYSICIAN FELT THE MOVEMENT WAS SNUG THROUGH THE INTRODUCER. THE 6935 WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other