BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM PATENCY CAPSULE, 1-PACK

    MDR report key: 6621653 · Received June 8, 2017

    Report

    Report Number
    9710107-2017-05269
    Event Type
    Death
    Date Received
    June 8, 2017
    Date of Event
    May 23, 2017
    Report Date
    May 24, 2017
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K090557
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM MEDTRONIC MEDICAL AFFAIRS CONFIRMED WITH THE CUSTOMER AS FOLLOWS; THE PATIENT HAD MULTIPLE CARCINOMAS OF THE SMALL BOWEL AND COLON. ACCORDING TO THE REPORTER THE CAPSULE STUDY WAS PLANNED DUE TO BLEEDING SUSPECTED OF STENOSIS. ADDITIONALLY THE REPORTER STATES THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS IN RELATION TO THE PATENCY CAPSULE (HOWEVER SUSPECTS THE PATIENT SYMPTOMS OF ILEUS WERE RELATED TO THE PATIENT¿S CONDITION). ACCORDING TO THE X-RAY THE CAPSULE WAS FULLY DISSOLVED, THE RFID TAG WAS LOCATED IN THE MIDDLE OF THE SMALL BOWEL. NO INTERVENTION WAS REQUIRED. THE PROBLEM BEGAN 10 DAYS AFTER INGESTION. THE PATIENT HAS DIED. AS PREVIOUSLY MENTIONED THE CAPSULE WAS FULLY DISSOLVED, BUT THE RFID TAG REMAINS INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM MEDICAL AFFAIRS ON (B)(6) 2017 STATED THE CAUSE OF DEATH WAS RELATED TO CARCINOMA AND THE DEATH WAS NOT RELATED TO THE PATENCY CAPSULE INGESTION.

    Description of Event or Problem · 1

    ACCORDING THE REPORTER THEY HAVE A PATIENT WHO HAS A RETAINED PATENCY CAPSULE. THE CAPSULE WAS ADMINISTERED ON (B)(6) AND THE RFID TAG SHOWED UP IN AN X-RAY TAKEN ON (B)(6) AFTER THE PATIENT SHOWED ILEUS SYMPTOMS. IT IS STATED THAT SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED AND IS SPECIFIED AS "CONTROL OF INTESTINE PASSAGE" AND IT IS STATED THAT IT IS UNKNOWN IF THE EVENT LEAD TO OR EXTENDED PATIENT HOSPITALIZATION, OR IF THERE WAS ANY INJURY CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402791 PILLCAM PATENCY CAPSULE, 1-PACK SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0109

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| O