BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2123508 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08140
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 8, 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
    OTHER

    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 ANALYSIS REVEALED NO ANOMALIES. IT WAS NOTED THAT ON THE DISTAL CONDUCTOR THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) AND BLOOD IN/ON HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD). VISUAL ANALYSIS NOTED THAT BLOOD WAS VISIBLE IN THE HELIX, PHOTOGRAPHS WERE TAKEN AND THAT THE BLOOD IN THE DISTAL CONDUCTOR MOST LIKELY ENTERED THROUGH THE IS-1 PIN BECAUSE NO INSULATION BREACHES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE HELIX MECHANISM OF THE LEAD WAS NOT COMPLETELY EXTENDED AFTER 30 TURNS DESPITE SUCCESSFUL TESTING PRIOR TO IMPLANT. THE LEAD WAS REMOVED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other