BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2050621 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05388
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY : (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). IT WAS NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD AND THE HELIX/LOBE MECHANISM ITSELF, THERE WAS A TIP SEAL OBSERVATION, AND THE LEAD APPEARED DAMAGE AT IMPLANT AND STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT THE "SCREW WOULD NOT DEPLOY" ON THE RIGHT VENTRICULAR LEAD. THERE WAS A QUESTION OF THE LEAD BEING DAMAGED VERSUS HAVING A DEFECT. ALSO NOTED, WAS A BEND IN THE INTRODUCER. THE LEAD WAS REMOVED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other