BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO GASTRIC CAPSULE

    MDR report key: 526486 · Received February 20, 2004

    Report

    Report Number
    526486
    Event Type
    Malfunction
    Date Received
    February 20, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/8/04: MEDTRONIC HAS REVIEWED THE INFO PROVIDED ON THE USER FACILITY REPORT AND COMPARED IT TO PREVIOUS COMPLAINTS ABOUT THIS PRODUCT. BASED UPON THE INFO AND THE REQUIREMENTS OF 21 CFR 803, MFR DID NOT FILE A MEDWATCH FORM 3500A FOR THIS EVENT, SINCE THERE WAS NO PT INJURY REPORTED AND MFR HAS NO PREVIOUS REPORTS OF THIS TYPE OF INCIDENT CAUSING A PT INJURY. MFR CONTINUES TO TREND THESE COMPLAINTS IN ACCORDANCE WITH 21 CFR 820 REQUIREMENTS. IN ADDITION, MFR HAS NOT RECEIVED THE DEVICE FOR EVAL AND THEREFORE, NO CONCLUSIONS CAN BE DRAWN AS TO THE ACTUAL CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A CAPSULE WAS PLACED IN A PT'S ESOPHAGUS. WHEN PHYSICIAN CHECKED TO SEE IF THE CAPSULE HAD ATTACHED, IT WAS DISCOVERED THAT IT HAD NOT. ANOTHER CAPSULE WAS REQUESTED, WHICH TOOK 15-20 MIN. [MINUTES] PREP [PREPARATION] TIME TO SOAK BEFORE IT COULD BE PLACED. THE PT WAS ANESTHETIZED FOR AN ADDITIONAL 15-20 MINUTES. THE NEXT CAPSULE WAS PLACED, BUT DID ATTACH APPROPRIATELY. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO GASTRIC CAPSULE GASTRIC CAPSULE NEZ MEDTRONIC GASTROENTEROLOGY/UROLOGY 1BE4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other ENDOSCOPY EQUIPMENT.