BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR TIMS THERAPY SYSTEM

    MDR report key: 2495968 · Received March 14, 2012

    Report

    Report Number
    3004824012-2012-00001
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 13, 2012
    Manufacturer
    NEURONETICS INC.
    Product Code
    OBP
    PMA / PMN Number
    K061053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE TREATING PHYSICIAN BELIEVES THIS EVENT IS NOT DEVICE RELATED. NEURONETICS BELIEVES THAT ASSESSMENT OF RELATEDNESS IS CONFOUNDED BY THE PATIENT'S HISTORY OF A GENERALIZED SEIZURE DISORDER, AND THE ACUTE DISCONTINUATION OF CLONAZEPAM. A ROLE FOR TMS IS NOT RULED OUT, HOWEVER, SINCE SEIZURES ARE KNOWN TO OCCUR WITH TMS THERAPY IN THE PRESENCE OF AGENTS OR CONDITIONS WHICH LOWER A PATIENT'S SEIZURE THRESHOLD INCLUDING MEDICATIONS, A HISTORY OF SEIZURE, AND THE USE OF TREATMENT PARAMETERS WHICH EXCEED THE GUIDELINES FOR SAFE USE OF TMS. THESE CONDITIONS RELATED TO THE SEIZURE ARE DESCRIBED IN THE NEUROSTAR TMS THERAPY SYSTEM USER MANUAL, "WARNINGS: RISK OF SEIZURE" WASSERMANN, E. M. (1998). RISK AND SAFETY OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION: REPORT AND SUGGESTED GUIDELINES FROM THE INTERNATIONAL WORKSHOP ON THE SAFETY OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION, 06/07/1996. ELECTROENCEPHALOGRAPHY AND CLINICAL NEUROPHYSIOLOGY, 108(1), 1-16.

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) WOMAN WITH RECURRENT DEPRESSION WITH IDEAS OF REFERENCE REQUIRING RECENT HOSPITALIZATION. SHE HAS A GENERALIZED SEIZURE DISORDER, WITH HER LAST SEIZURE OCCURRING IN 2010. SHE WAS RECEIVING TMS THERAPY FOR HER DEPRESSION. APPROXIMATELY 19 MINUTES INTO HER 64TH TMS SESSION, SHE WAS NOTED TO HAVE GENERALIZED TONIC-CLONIC SEIZURE WITH LOSS OF CONSCIOUSNESS, LASTING LESS THAN 3.5 MINUTES, FOLLOWED BY APPROXIMATELY ONE HOUR OF POST-ICTAL DISORIENTATION. AFTER RECOVERING FROM HER SEIZURE, SHE WAS ABLE TO GO HOME. THE TREATMENT PROTOCOL, 4 SECONDS OF 10 PULSE PER SECOND TRAINS AT 140% OF MOTOR THRESHOLD WITH A 26 SECOND INTERTRAIN INTERVAL (TOTAL 2500 PULSES) VARIED FROM THE NEUROTICS LABELED TREATMENT PROTOCOL, AND EXCEEDS THE STIMULATION PARAMETERS RECOMMENDED IN TREATMENT GUIDELINES FOR SAFE USE OF TIMS (WASSERMAN, 1998). TWO DAYS PRIOR TO THE EVENT, SHE SELF-DISCONTINUED HER CLONAZEPAM WITHOUT INFORMING THE TIMS TREATMENT STAFF. THE TREATING PHYSICIAN ASSESSED THE EVENT AS NOT DEVICE RELATED, BUT RATHER CAUSED BY CLONAZEPAM WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTAR TIMS THERAPY SYSTEM TRANSCRANIAL MAGNETIC STIMULATOR (OBP) OBP NEURONETICS INC. 81-00315-000

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other CLONAZEPAM 1MG TID| DEPAKOTE 250MG TID