BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2223620 · Received August 25, 2011

    Report

    Report Number
    2649622-2011-13718
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE REPLACEMENT IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND ONE LEAD. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 88 YR Death