BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1990416 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01975
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 9, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY : (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED; THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DISTAL CONDUCTOR AND OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY HAD A BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS A TIP SEAL OBSERVATION. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMALL R-WAVES WERE NOTED AND THERE WAS AND ATTEMPT TO MOVE THE LEAD, SUBSEQUENTLY THE "LEAD WAS RETRACTED 1 TIME ONLY 12 TURNS AND NOW CANNOT BE EXTENDED.". IT WAS ALSO REPORTED THAT THERE WAS AN INSULATION BREECH DUE TO USING THE LEAD TO GET A NEW GUIDE WIRE DOWN. THE LEAD WAS NOT IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    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 86 YR Other