BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791130 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15408
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. IT WAS VISUALLY NOTES THAT THE INTRODUCER WAS NOT RETURNED. A FRESH INTRODUCER WAS USED TO PERFORM THE TEST, AND THE TEST PASSED. PER ENGINEER REQUEST SEVEN OUTSIDE DIAMETER READING WERE TAKEN OF THE OUTER TUBING AND EXPOSED DEFIBRILLATION COIL. ALL MEASUREMENTS WERE TAKEN FROM THE PROXIMAL END OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR [RV] LEAD WAS BINDING TO THE INTRODUCER; THIS CAUSED THE PHYSICIAN TO HAVE "GREAT DIFFICULTY" REMOVING THE INTRODUCER FROM THE LEAD WHICH IN TURN CAUSED THE RV LEAD TO DISLODGE. THE PHYSICIAN COMMUNICATED THAT IT FELT LIKE THERE WAS A "CHEMICAL BOND" BETWEEN THE SHEATH AND RV LEAD. THE LEAD WAS REMOVED AND A DIFFERENT RV LEAD 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB