BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6010815 · Received October 7, 2016

    Report

    Report Number
    9710107-2016-01040
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    May 18, 2018
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THOUGHT HE DEFECTIVE DEVICE WAS NOT PROVIDED FOR EVALUATION, A COPY OF THE DATA WAS RECEIVED. BASED ON THE DATA COLLECTED, THE RECORDING WAS 00:14 MINUTES INSTEAD OF THE INTENDED 24, 48 OR 96 HOURS. DUE TO THE LIMITED DATA AVAILABLE THE CONCLUSION OF THE INVESTIGATION IS THAT THE CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ESOPHAGEAL PROCEDURE, THE BRAVO CAPSULE YIELDED A SHORT STUDY. THE STUDY WAS ONLY 15 MINUTES LONG WITH A STRAIGHT RED LINE. THE PATIENT KEPT THE RECORDER THE ENTIRE 48 HOURS. THE PATIENT HAD CALLED THE DOCTOR BUT THE DOCTOR DID NOT GET THE CALL AND THE PATIENT WAS ADVISED TO CONTINUE WEARING THE EQUIPMENT. THE ACCOUNT CONFIRMED THAT A REPEAT PROCEDURE WAS NECESSARY. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662618 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1