BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMF SPINALOGIC

    MDR report key: 8582060 · Received May 6, 2019

    Report

    Report Number
    3012446970-2019-00012
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 30, 2019
    Manufacturer
    DJO, LLC
    Product Code
    LOF
    UDI-DI
    00888912011495
    PMA / PMN Number
    P910066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SPINALOGIC (PART NUMBER 01-207-0007, SERIAL NUMBER (B)(4) WAS RETURNED FOR EVALUATION. TESTING OF THE DEVICE INCLUDED FULL TREATMENT AT A TEST STATION WITH RESULTS OBSERVED TO BE WITHIN SPECIFICATIONS. THE REPORTED EVENT COULD NOT BE DUPLICATED; NO FAILURE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USAGE OF THE DEVICE DURING TREATMENT ALTERED THE PATIENT'S HEART RATE. AT THE 1ST TREATMENT, AFTER ABOUT THREE MINUTES, HER HEART SKIPPED A BEAT AND STARTED POUNDING. SHE TOOK OFF THE DEVICE AND HER RAPID HEARTBEAT LASTED ABOUT THIRTY MINUTES. WHEN SHE TRIED HER SECOND TREATMENT, SHE FELT LIKE PINS AND NEEDLES WERE STABBING HER. THE PATIENT WAS ADVISED TO STOP ANY USE OF THE DEVICE IMMEDIATELY AND CALL HER PHYSICIAN. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO DISCONTINUE USE. THE PATIENT HAS HAD A DOUBLE BYPASS AND STENTS WERE PUT IN. SHE ALSO HAS A WIRE AROUND HER STERNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376009 CMF SPINALOGIC STIMULATOR, BONE GROWTH, NON-INVASIVE LOF DJO, LLC 01-207-0007 00888912011495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention