BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1992430 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02839
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 31, 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
    MN, 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) DISTAL CONDUCTOR DISTORTED. ADDITIONAL FINDINGS OF DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD), BLOOD IN/ON HELIX MECHANISM, TIP SEAL OBSERVATION AND DAMAGED AT IMPLANT. ANALYST COMMENTED THAT HELIX CAN NOT EXTEND AND RETRACT DUE TO DISTAL CONDUCTOR DISTORTION WITHIN THE CONNECTOR. FULL LEAD RETURNED AND ANALYZED.

    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 PHYSICIAN HAD DIFFICULTIES EXTENDING THE HELIX OF THE LEAD DURING THE IMPLANT PROCEDURE. THE LEAD WAS NOT USED AND A DIFFERENT LEAD WAS 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 67 YR Other