BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2052992 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05733
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATION OF BLOOD IN/ON HELIX MECHANISM. (B)(4): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF INNER TUBING KINKED/BUCKLED, APPARENT EXPLANT DAMAGE AND BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, TWO LEADS WERE ATTEMPTED BUT NEITHER LEAD WAS ABLE TO PASS THROUGH THE SUBCLAVIAN DUE TO TORTUOSITY. THE TWO LEADS WERE NOT USED. 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 49 YR Other