BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1792645 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07050
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    December 15, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) HELIX DISENGAGED FROM HELICAL CHANNEL AND BLOOD NOTED ON HELIX MECHANISM; THE ANALYST NOTED THAT THE HELIX WILL NOT EXTEND BECAUSE IT IS OVER-RETRACTED; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED WITH NO INFORMATION, BUT APPEARS TO AN ATTEMPTED BUT NOT IMPLANTED LEAD. WE WILL CONDUCT FOLLOW-UP TO DETERMINE WHY THE LEAD WAS NOT USED. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention