BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2032087 · Received March 28, 2011

    Report

    Report Number
    2649622-2011-04242
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THE RELATEDNESS OF THE DEATH TO THE DEVICE IS UNKNOWN. THE LAST OFFICE VISIT HAD BEEN APPROXIMATELY FIVE WEEKS PRIOR TO DEATH "AND THERE IS NOTHING NOTED." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THE RELATEDNESS OF THE DEATH TO THE DEVICE IS UNKNOWN. THE LAST OFFICE VISIT HAD BEEN APPROXIMATELY FIVE WEEKS PRIOR TO DEATH "AND THERE IS NOTHING NOTED." FOLLOW UP WITH THE CARDIOLOGIST REPORTED THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE DUE TO ISCHEMIC CARDIOMYOPATHY.

    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 69 YR Death