BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 1833132 · Received August 24, 2010

    Report

    Report Number
    9710107-2010-00563
    Event Type
    Death
    Date Received
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GIVEN IMAGING LTD. HERMON BUILDING
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATE THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PTS WITH CARDIAC PACEMAKERS OR OTHER IMPLANTED ELECTROMEDICAL DEVICES, SUCH AS AICD (AN IMPLANTED CARDIOVERTER DEFIBRILLATOR).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PT HAS INGESTED A PILLCAM SB2 CAPSULE MORNING OF (B)(6)2010 AND HE PASSED AWAY THE NEXT DAY WHILE SEATED ON A COUCH. THE PT HAD A HISTORY OF CORONARY ARTERY DISEASE AND AN AICD (AN IMPLANTED CARDIOVERTER DEFIBRILLATOR). THE CAPSULE WAS INGESTED UNEVENTFULLY. THE STUDY WAS PERFORMED TO INVESTIGATE FOR IRON DEFICIENCY. THE CORONER DECIDED NOT TO PERFORM AN AUTOPSY. THE DEATH WAS THOUGHT TO BE DUE TO A CARDIAC EVENT. THE VIDEO SHOWED THE CAPSULE TO HAVE REMAINED IN THE STOMACH AT THE END OF THE STUDY. THERE WERE RESIDUAL FOOD REMNANTS IN THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. HERMON BUILDING PILLCAM SB2 CAPSULE LOT # 2010-02/12460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death