BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811718 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15884
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 7, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DISTAL CONDUCTOR WAS DISTORTED AND THE DEFIBRILLATION CONDUCTOR WAS CUT. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THE OUTER INSULATION WAS BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. VISUAL ANALYSIS REVEALED THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD REQUIRED SEVERAL TURNS FOR EXTENSION AND RETRACTION OF THE HELIX. IT WAS ALSO NOTED THE HELIX WOULD "POP" OUT RATHER THAN GRADUALLY EXTEND. SEVERAL IMPLANT ATTEMPTS WERE MADE WITH THE LEAD WITHOUT SUCCESS. THE LEAD WAS NOT USED AND A NEW LEAD WAS 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 NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other