BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1792507 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07127
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    April 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) DISTAL CONDUCTOR DISTORTED; FULL LEAD WAS RETURNED FOR ANALYSIS. THE LEAD WAS RETURNED WITH THE HELIX EXTENDED. THE HELIX WILL NOT EXTEND DUE TO THE DISTORTED DISTAL COIL IN THE CONNECTOR. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR AND BLOOD IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD WAS UNABLE TO FIX SINCE THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT 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. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention