BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2203518 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11707
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THE LEAD WAS DAMAGED AT IMPLANT. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED, THE INNER TUBING WAS KINKED/BUCKLED, AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD WAS UNABLE TO OBTAIN SENSING/PACING IMPEDANCES WHEN CONNECTED BIPOLAR. WHEN THE LEAD WAS TESTED DISTAL COIL TO RING, IT RESOLVED THE PROBLEM. A DISTAL ELECTRODE MALFUNCTION WAS SUSPECTED. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS ATTEMPTED. THE SECOND LEAD WAS ALMOST IMPOSSIBLE TO MOVE BACK AND FORTH THROUGH THE INTRODUCER EVEN WHEN THE SAFE SHEATH WAS PARTIALLY SPLIT. THE LEAD WAS NOT IMPLANTED AND WAS REPLACED WITH A DIFFERENT LEAD. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other