BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 1984177 · Received February 10, 2011

    Report

    Report Number
    2647346-2011-00092
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    December 20, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2010. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY (RECEIVING THERAPY WITH MAGNET IN PLACE AND PATIENT ALERT) IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 21JAN2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. 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 BY THE CALLER, THAT THERE WAS AN ORDER BY THE PHYSICIAN TO TURN OFF THE IMPLANTABLE CARDIAC DEFIBRILLATOR ON THIS HOSPICE PATIENT AND THEY WERE "TRYING TO TURN OFF WITH THE CARELINK MONITOR". ALSO REPORTED THAT THE PATIENT WAS RECEIVING THERAPY WITH A MAGNET IN PLACE AND THERE WAS INTERMITTENT BEEPING HEARD. THE DEVICE WAS DEACTIVATED BY THE MANUFACTURERS REPRESENTATIVE AND SUBSEQUENTLY THE PATIENT DIED THREE DAYS LATER. FOLLOW UP DETERMINED THAT THE THERAPY DELIVERED WAS APPROPRIATE. THE CAUSE OF DEATH HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD