BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2101271 · Received May 24, 2011

    Report

    Report Number
    2649622-2011-07644
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    March 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Description of Event or Problem · 1

    IT WAS FOUND BY STAFF WHILE INVESTIGATING A PREVIOUSLY RETURNED DEVICE FROM THE PATIENT, THAT THE PATIENT HAD EXPIRED. FOLLOW UP HAS REVEALED THAT THE PATIENT RECEIVED FREQUENT AND MULTIPLE APPROPRIATE SHOCKS DUE TO FREQUENT VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT HAD BEEN TO THE EMERGENCY ROOM MANY TIMES AND WAS TRANSFERRED TO A LARGE MEDICAL CENTER FOR ADDITIONAL INTERVENTIONS. AN ABLATION WAS DONE. SOON AFTER DISCHARGE FROM THE HOSPITAL BEGAN HAVING THE FREQUENT VENTRICULAR TACHYCARDIA. EXACT CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L