BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2131161 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10424
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. IT WAS FOUND THAT THE HELIX DISENGAGED FROM HELICAL CHANNEL. IT WAS ALSO NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED AND THE INNER TUBING WAS KINKED/BUCKLED. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND (SLEEVE HEAD). THE TIP SEAL WAS ALSO OBSERVED. VISUALLY, IT WAS NOTED THAT THE LEAD INSULATION WAS CUT AT 54.5CM WITH A SCALPEL TO INJECT ALCOHOL TO REMOVE THE STYLET FROM THE DISTAL COIL WHICH WAS STUCK DUE TO DRIED BLOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS POSITIONING AND FIXATION DIFFICULTIES AS THE LEAD HELIX COULD NOT BE EXTENDED AFTER REPOSITIONING. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS POSITIONING AND FIXATION DIFFICULTIES AS THE LEAD HELIX COULD NOT BE EXTENDED AFTER REPOSITIONING. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS POSITIONING AND FIXATION DIFFICULTIES AS THE LEAD HELIX COULD NOT BE EXTENDED AFTER REPOSITIONING. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other