BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM

    MDR report key: 6389218 · Received March 8, 2017

    Report

    Report Number
    9710107-2017-05082
    Event Type
    Death
    Date Received
    March 8, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 14, 2017
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: MEDTRONIC'S DIRECTOR OF MEDICAL AFFAIRS DISCUSSED THE PATIENT CASE WITH THE TREATING PHYSICIAN, AND THE DETAILS ARE AS FOLLOWS; THE PATIENT WAS AN (B)(6) MAN IN GOOD HEALTH APART FROM COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE). ON (B)(6) 2017, HE FAINTED AND VISITED THE EMERGENCY ROOM. HGB(HEMOGLOBIN)/HCT(HEMATOCRIT) WERE 7.7/21.2 AND CONTINUED TO DECLINE ON A SUBSEQUENT TEST, SO A TRANSFUSION WAS ADMINISTERED (HE RECEIVED A TOTAL OF 14 UNITS OF BLOOD DURING THE HOSPITALIZATION). AN EGD(ESOPHAGOGASTRODUODENOSCOPY) WAS PERFORMED WITHOUT THE BLEEDING SOURCE IDENTIFIED. THE COLONOSCOPY WAS POSTPONED FOR TWO DAYS AND ALSO DID NOT IDENTIFY THE SOURCE. DURING THIS TIME, THE PATIENT BECAME DISORIENTED AND EDEMATOUS. THE FOLLOWING DAY, PILLCAM SB WAS ENDOSCOPICALLY PLACED IN THE DUODENUM DUE TO A ZENKER¿S DIVERTICULUM. THE PROCEDURE RAN FOR 12 HOURS. THE NEXT DAY, THE INTERNAL MEDICINE PHYSICIAN REPORTED THAT THEY DIDN¿T FIND THE BLEED, BUT IT LATER WAS UNCLEAR WHETHER THE PILLCAM RESULTS WERE AVAILABLE (THE PATIENT'S DAUGHTER REPORTED THAT THEY WERE NOT IN THE CHART FOUR DAYS AFTER THE PROCEDURE AND SHE ASKED FOR THE RESULTS REPEATEDLY WITHOUT SUCCESS). SECONDARY TO CONTINUED ANEMIA AND ADVANCED AGE, THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND DIED ON (B)(6) 2017. THE TREATING PHYSICIAN REPORTED THAT THERE WAS NO PROBLEM WITH THE DR3OR THE PILLCAM SB PROCEDURE. HE DID NOT RECALL BEING UNABLE TO ACCESS THE REAL TIME VIEWER. THE STUDY WAS INTERPRETED AND WAS DOCUMENTED IN THE EMR(ELECTRONIC MEDICAL RECORDS). PILLCAM WAS COMPLETELY UNRELATED TO THE DEATH AND PERFORMED AS EXPECTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT'S DAUGHTER CALLED TO REQUEST INFORMATION REGARDING THE PILLCAM SB3 PROCEDURE AND HAD SPECIFIC QUESTIONS REGARDING HER FATHER'S PROCEDURE WHOM IS NOW DECEASED. MEDTRONIC MEDICAL AFFAIRS PHYSICIAN CONTACTED THE PATIENT'S DAUGHTER IN ORDER TO LEARN ADDITIONAL DETAILS AND CONTACT INFORMATION FOR THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169911 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0501

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death