BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2053041 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05751
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 26, 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
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, THERE WAS A TIP SEAL OBSERVATION, THE LEAD WAS STRETCHED, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE HELIX WILL NOT FUNCTION PROPERLY AT THIS TIME DUE TO THE AMOUNT OF DRIED BLOOD IN THE DISTAL CONDUCTOR AND THE SLEEVEHEAD.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE (B)(6). 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO "FIXATE" THE LEAD, BUT WAS UNABLE. THE LEAD WAS REMOVED AND REPLACED. NO KNOWN 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB