BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2032091 · Received March 28, 2011

    Report

    Report Number
    2649622-2011-04230
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    November 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER IMPLANTABLE PULSE GENERATOR REPLACEMENT. FURTHER INFORMATION OBTAINED INDICATED THE PATIENT ARRIVED TO THE EMERGENCY ROOM PULSELESS, RESCUE EFFORTS WERE BEGUN, THE PATIENT WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION AND SUBSEQUENTLY DIED SEVEN DAYS LATER. THE CAUSE OF DEATH IS CARDIAC ARREST, HYPOXIA AND CEREBRAL ANOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| L| R