BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2121649 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07807
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    November 19, 2010
    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
    OH, US
    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 AND ANALYZED. ANALYSIS FOUND THAT THE HELIX DISENGAGED FROM THE HELICAL CHANNEL, BLOOD/BODY FLUID WAS FOUND IN DISTAL CONDUCTOR (NOT OBSTRUCTED), BLOOD WAS NOTED IN/ON HELIX/LOB MECHANISM AND MECHANISM (SLEEVE HEAD), AND TIP SEAL OBSERVATION WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RESISTANCE BETWEEN THE LEAD AND STYLET DUE TO BLOOD IN THE LUMEN OF THE LEAD AND THE LEAD WOULD NOT ADVANCE. THE LEAD WAS WITHDRAWN WITHOUT INCIDENT AND NOT IMPLANTED.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 64 YR Other