BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1890517 · Received November 4, 2010

    Report

    Report Number
    2649622-2010-12029
    Event Type
    Death
    Date Received
    November 4, 2010
    Date of Event
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 REPORTED THE PATIENT DIED. FOLLOW UP WITH THE CLINIC REVEALED THE DATE OF DEATH TO BE (B)(6) 2010 AND THERE WAS NO ALLEGATION OF DEVICE RELATEDNESS. THE DEVICE HAD BEEN SHOCKING PATIENT APPROPRIATELY. WHILE PATIENT AT CLINIC ON (B)(6) 2010, HE WENT INTO VENTRICULAR FIBRILLATION AND THE DEVICE SUCCESSFULLY SHOCKED HIM OUT OF IT. PATIENT REFUSED TO GO TO THE HOSPITAL THAT DAY, BUT WAS ADMITTED THE NEXT. THE NURSE DESCRIBED THIS PATIENT AS "A TRAIN WRECK." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death