BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2201585 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11139
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 3, 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
    UK
    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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DISTAL CONDUCTOR, THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM SLEEVE HEAD AND ON THE HELIX MECHANISM ITSELF, AND THERE WAS A TIP SEAL OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO EXTEND AND RETRACT THE LEAD HELIX. AFTER SECOND REPOSITIONING, THE HELIX MECHANISM WAS RETRACTED BUT HELD THE TORQUE IN THE LEAD CAUSING THE HELIX MECHANISM TO PARTIALLY EXTEND AGAIN. THE LEAD WOULD NOT FULLY EXTEND ANYMORE. THE MARKERS SHOWED THAT THE LEAD WAS STILL RETRACTED. AFTER REMOVING THE LEAD AND TRYING IT ON THE TABLE, IT WAS POSSIBLE AGAIN TO RETRACT AND EXTEND THE HELIX, HOWEVER THERE WAS STILL A LOT OF TORQUE HELD ON THE LEAD. THE LEAD WAS NOT 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 Other