BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTA SIGMA

    MDR report key: 18813097 · Received February 29, 2024

    Report

    Report Number
    3020533-2024-00001
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    June 23, 2023
    Report Date
    March 21, 2024
    Manufacturer
    MECTA LLC
    Product Code
    QGH
    PMA / PMN Number
    K192834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FROM A MEDWATCH REPORT FILED BY A PATIENT. ACCORDING TO THE DOCTORS, THE MECTA SIGMA DEVICE WAS WORKING AS EXPECTED TO PATIENTS BEFORE, DURING AND AFTER THE JEREMY'S ECT TREATMENTS. THE DEVICE PASSES ALL EXHAUSTIVE INTERNAL START UP AND AFTER TREATMENT INTERNAL TESTS. INTERVIEW WITH THE DOCTOR DISCLOSED THE FOLLOWING: - THE DEVICE WORKED VERY WELL, JUST AS EXPECTED. - THEY TELL ALL OF THEIR PATIENTS TO NOT EAT AFTER MIDNIGHT THE NIGHT BEFORE AND TO EMPTY THEIR BOWELS IN THE MORNING BEFORE TREATMENT. - VERY FEW PATIENTS CAN LOSE CONTROL OF THEIR BOWELS, BUT IT CAN HAPPEN.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FROM A MEDWATCH REPORT FILED BY A PATIENT. ACCORDING TO THE DOCTORS, THE MECTA SIGMA DEVICE WAS WORKING AS EXPECTED TO PATIENTS BEFORE, DURING AND AFTER THE JEREMY'S ECT TREATMENTS. THE DEVICE PASSES ALL EXHAUSTIVE INTERNAL START UP AND AFTER TREATMENT INTERNAL TESTS. INTERVIEW WITH THE DOCTOR DISCLOSED THE FOLLOWING: THE DEVICE WORKED VERY WELL, JUST AS EXPECTED. THEY TELL ALL OF THEIR PATIENTS TO NOT EAT AFTER MIDNIGHT THE NIGHT BEFORE AND TO EMPTY THEIR BOWELS IN THE MORNING BEFORE TREATMENT. VERY FEW PATIENTS CAN LOSE CONTROL OF THEIR BOWELS, BUT IT CAN HAPPEN. FOLLOW UP REPORT: NEW INFORMATION HAS NOT BEEN ADDED OR HAS BECOME AVAILABLE. THE ORIGINAL REPORT IS UNALTERED. THEREFORE, THERE IS NO CHANGES TO THE EVENT, THE INVESTIGATION, OR THE CONCLUSION. THE FOLLOW UP IS THAT THE INITIAL REPORTER HAS UPDATED THEIR CONTACT INFORMATION AND HAS ASKED TO REMAIN CONFIDENTIAL. THEREFORE, WE HAVE REMOVED THEIR CONTACT INFORMATION FROM OUR REPORT. THE ORIGINAL REPORT HAD THE WRONG DEVICE PRODUCT CODE. THIS HAS BEEN CORRECTED FROM GXC TO QGH.

    Description of Event or Problem · 0

    PATIENT WAS RECOMMENDED FOR ECT (ELECTROCONVULSIVE THERAPY) TREATMENT. THE PATIENT REPORTS THE FOLLOWING: 1) THEY HAD A SEVERE HEADACHE POST TREATMENT AND WAS GIVEN TRAMADOL. 2) THEY HAD FECAL INCONTINENCE, PAIN UP AND DOWN BACK AND NECK, AND CHEST PAIN. NOTE: THE PATIENT HAS HAD THEIR NECK FUSED, HERNIATED DISC PROBLEMS AND OTHER SPINAL ISSUES IN THE PAST THAT IS UNRELATED TO THE ECT TREATMENT.

    Description of Event or Problem · 0

    PATIENT WAS RECOMMENDED FOR ECT (ELECTROCONVULSIVE THERAPY) TREATMENT. THE PATIENT REPORTS THE FOLLOWING: THEY HAD A SEVERE HEADACHE POST TREATMENT AND WAS GIVEN TRAMADOL. THEY HAD FECAL INCONTINENCE, PAIN UP AND DOWN BACK AND NECK, AND CHEST PAIN. NOTE: THE PATIENT HAS HAD THEIR NECK FUSED, HERNIATED DISC PROBLEMS AND OTHER SPINAL ISSUES IN THE PAST THAT IS UNRELATED TO THE ECT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213139 MECTA SIGMA ELECTROCONVULSIVE THERAPY DEVICE QGH MECTA LLC MECTA SIGMA
    524823 MECTA SIGMA ELECTROCONVULSIVE THERAPY DEVICE QGH MECTA LLC MECTA SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other MECTA SIGMA| MECTA SIGMA