BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT 3: BRIGADIER

    MDR report key: 8727309 · Received June 24, 2019

    Report

    Report Number
    2133409-2019-00005
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    00850725007026
    PMA / PMN Number
    K143359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT DESCRIBED THAT THE DEVICE SHOCKED HER IN THE MIDDLE OF HER HEART, SPECIFICALLY THE ELECTRODES. BASED ON THE REPORTED ALLEGATION OF "PATIENT FELT SHOCK IN THE MIDDLE OF HEART" WAS ASSESSED BY A HEALTH PROFESSIONAL AND WAS REPORTED TO FDA DUE TO PATIENT'S SUBJECTIVE CLAIM OF SERIOUS INJURY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION ASSOCIATED WITH THE REPORTED ALLEGATION. A REPLACEMENT DEVICE WAS SENT AND THE PATIENT CONTINUED THE SERVICE WITH NO FURTHER PROBLEMS. THE PATIENT HAS NOT RETURNED THE DEVICE ASSOCIATED WITH THE ALLEGATION. THE DEVICE HISTORY RECORD WAS REVIEWED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. THERE ARE NO REPORTS OF PREVIOUS ALLEGATIONS SIMILAR TO THE ONE ASSOCIATED WITH THIS CASE DOCUMENTED ON FILE. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 0

    ON 22-MAY-2019, THE INITIAL REPORTER (PATIENT) NOTIFIED (B)(6) THAT THE "DEVICE SHOCKED ME IN THE MIDDLE OF MY HEART". THE PATIENT INDICATED THAT THE SHOCK SENSATION WAS COMING FROM THE ELECTRODES. THE PATIENT DID NOT SEEK MEDICAL ATTENTION FOR THE ALLEGED EVENT. NOTE: BRAEMAR MANUFACTURING, LLC BECOME AWARE DATE IS 30-MAY-2019.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE INITIAL REPORTER REPORTED (PATIENT) NOTIFIED (B)(4), LLC (REGISTRATION NUMBER 3027765) THAT THE "DEVICE SHOCKED ME IN THE MIDDLE OF MY HEART". THE PATIENT INDICATED THAT THE SHOCK SENSATION WAS COMING FROM THE ELECTRODES. THE PATIENT DID NOT SEEK MEDICAL ATTENTION FOR THE ALLEGED EVENT. NOTE: THE BRAEMAR MANUFACTURING, LLC BECOME AWARE DATE IS 30-MAY-2019.

    Additional Manufacturer Narrative · 1

    BRAEMAR MANUFACTURING, LLC HAVE NOT RECEIVED THE AFFECTED DEVICE BACK FOR EVALUATION AT THE TIME OF THIS SUBMISSION. THE AFFECTED DEVICE HAS NOT BEEN RETURNED BY THE PATIENT. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE INITIAL REPORTED (PATIENT) NOTIFIED LIFEWATCH SERVICES, LLC ((B)(4)) THAT THE "DEVICE SHOCKED ME IN THE MIDDLE OF MY HEART". THE PATIENT INDICATED THAT THE SHOCK SENSATION WAS COMING FROM THE ELECTRODES. THE PATIENT DID NOT SEEK MEDICAL ATTENTION FOR THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521351 ACT 3: BRIGADIER ACT 3: BRIGADIER DSI BRAEMAR MANUFACTURING, LLC ACT 3: BRIGADIER 00850725007026

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR