BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2131964 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10615
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS ALSO NOTED THAT SEVERAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX PARTLY EXTENDED, BLOOD AND TISSUE ON IT AND THE DISTAL CONDUCTOR WAS DISTORTED WITHIN THE CONNECTOR. THE BLOOD AND TISSUE ON THE HELIX CAUSED THE HELIX TO NOT RETRACT AND THE DISTAL CONDUCTOR THEN BECAME DISTORTED WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THE RIGHT VENTRICULAR LEAD WAS ATTEMPTED DUE TO POSITIONING DIFFICULTIES AND "SCREW MECHANICAL FAILURE". THE LEAD WAS REMOVED AND REPLACED WITH A NEW 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other