BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM

    MDR report key: 14958574 · Received July 8, 2022

    Report

    Report Number
    9710107-2022-00158
    Event Type
    Death
    Date Received
    July 8, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 8, 2022
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    UDI-DI
    07290101364085
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION NOR HAS THE DEVICE BEEN EVALUATED BY THE MEDTRONIC SERVICE ENGINEER. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    ACCORDING TO THE REPORTER, A PATIENT INGESTED A CAPSULE 8:00 IN THE MORNING OF (B)(6) 2022, WHO WAS UNDERGOING CAPSULE ENDOSCOPY FOR IRON DEFICIENT ANEMIA. THE PATIENT HAD A HISTORY OF ADENOCARCINOMA INCLUDED PRIOR GASTROSCOPY AND COLONOSCOPY FOR POLYPS. THE PATIENT WAS REPORTEDLY FINE POST INGESTION AT THE ENDOSCOPY UNIT. THE PATIENTS' HUSBAND RANG THE ENDOSCOPY UNIT EARLY AFTERNOON REPORTING THE PATIENT HAD SEVERE ABDOMINAL PAIN AND WAS NAUSEOUS. THEY WERE ADVISED TO RETURN TO ENDOSCOPY UNIT AS SOON AS POSSIBLE, HOWEVER, AMBULANCE SERVICE WAIT TIME WAS 2 HOURS. THEREFORE, THEY WERE ADVISED TO RETURN UNDER THEIR OWN TRANSPORT. PATIENT WAS DRIVEN BACK TO ENDOSCOPY UNIT AND WAS ASSESSED. THEN THEY WERE TRANSFERRED TO EMERGENCY DEPARTMENT WHERE A CT SCAN WAS REQUESTED. THE CT SCAN INDICATED CAPSULE WAS LOCATED IN THE PATIENTS' CECUM. THE PATIENT REPORTEDLY HAD VERY LOW BLOOD PRESSURE, AND WAS CLINICALLY UNWELL WITH SEPSIS. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, HOWEVER, THE PATIENT PASSED AWAY SHORTLY AFTER ADMISSION. ALLEGEDLY INVESTIGATION INDICATED PATIENTS' CAUSE OF DEATH WAS ACUTE PANCREATITIS. THE HEALTH CARE TEAM MENTIONED THAT ACUTE PANCREATITIS AND RELATED FINDINGS ON CT SCAN (BILIARY DILATION, COULD NOT RULE STONES, ADJACENT DUODENAL THICKENING) WERE UNRELATED TO PASSAGE OF THE CAPSULE, WHICH APPEARED TO HAVE BEEN VISUALIZED IN THE CECUM. THE PATIENT HAD SEVERAL UNDERLYING DISEASES INCLUDING IRON DEFICIENCY ANEMIA AFTER NEGATIVE ESOPHAGOGASTRODUODENOSCOPY AND COLONOSCOPY WHICH HAD PROMPTED THE CAPSULE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826941 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0391 56446U 07290101364085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death