BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2050809 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05426
    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/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 FOR (B)(4): NO ANOMALIES FOUND. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF DEFIB CONDUCTOR DISTORTED AND CUT AND LEAD DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR LEAD, AN ACTIVE FIXATION DEVICE WAS CHOSEN DUE TO THE PATIENT'S ANATOMY. DURING THE PROCEDURE, THE LEAD WAS POSSIBLY "KINKED" WHILE MANEUVERING INTO POSITION AND WAS POTENTIALLY DAMAGED. THE LEAD IMPEDANCES AND CAPTURE THRESHOLDS MEASURED HIGH. THE LEAD WAS ATTEMPTED BUT NOT USED AND REPLACED WITH A NEW LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 4574 IMPLANTABLE PACING LEAD