BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790537 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14425
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THERE WAS "SIGNIFICANT NOISE" AND A VERY SMALL R WAVE ON THE VENTRICULAR ELECTROGRAM. MULTIPLE TESTING CABLES AND DIFFERENT PACING SITES WERE ATTEMPTED WITH LITTLE CHANGE. ALSO, OTHER CHRONIC LEADS WERE TESTED WITH "NO PROBLEMS". THE LEAD WAS REMOVED AND A NEW 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other