BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2202016 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11260
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THERE WAS ALSO BLOOD IN/ON THE HELIX MECHANISM AND SLEEVE HEAD. THE TIP SEAL WAS OBSERVED OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR LEAD IMPLANTATION WAS ATTEMPTED, BUT NOT SUCCESSFUL BECAUSE THE HELIX WOULD NOT EXTEND. THE LEAD WAS REMOVED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other