BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM SB2

    MDR report key: 1397172 · Received January 15, 2009

    Report

    Report Number
    9710107-2009-00001
    Event Type
    Death
    Date Received
    January 15, 2009
    Manufacturer
    GIVEN IMAGING LTD.
    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

    THE PHYSICIAN INVOLVED STATED THAT THE MEDICAL DEVICE OR POTENTIAL INTERFERENCE FROM THE PILLCAM SB CAPSULE WAS NOT RELATED TO THE CAUSE OF DEATH. INSTEAD, IT WAS FELT TO BE THE PATIENTS SEVERE UNDERLYING HEART DISEASE, WHICH WAS AN ACTIVE PROBLEM PRIOR TO THE CAPSULE ENDOSCOPY PROCEDURE. THE PHYSICIAN STRONGLY BELIEVED THAT THE REASON FOR PATIENT DEATH WAS A MYOCARDIAL INFARCT, DUE TO THE HISTORY OF SEVERE HEART DISEASE. IN ADDITION, THE CE WAS PERFORMED IN A PATIENT WITH AN IMPLANTED ELECTROMEDICAL DEVICE, WHICH IS A CONTRAINDICATION. GIVEN IMAGING HAS REQUESTED THE COPY OF PATIENT'S VIDEO FOR INTERNAL EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT SWALLOWED THE CAPSULE SOMETIME IN 2008 AT 7:14 A.M. AFTER UNDERGOING PREP WITH HALFLYTELY (WHICH IS THE STANDARD SB PREP AT THAT FACILITY). THE PATIENT SEEMED WELL, BUT THAT AFTERNOON AT ABOUT 2:45, SHE DEVELOPED SHORTNESS OF BREATH. HER CONDITION WORSENED AND SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE SHE DIED. NO POST MORTEM EXAMINATION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 PILLCAM SB2 NEZ GIVEN IMAGING LTD. SB2 2008-09/7317S

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death