BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTAR TMS THERAPY SYSTEM

    MDR report key: 2757435 · Received September 20, 2012

    Report

    Report Number
    3004824012-2012-00002
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    August 17, 2012
    Report Date
    September 20, 2012
    Manufacturer
    NEURONETICS, INC.
    Product Code
    OBP
    PMA / PMN Number
    K061053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TREATMENT PARAMETERS - MOTOR THRESHOLD: 0.85. TREATMENT PROTOCOL: DLPFC AT 20HZ, 80% MT, 2 SEC/28 SEC X 1000 PULSES FOLLOWED BY LEFT DLFPC 20 HZ AT 119% MT, 2 SEC ON, 28 SEC OFF, FOR 2400 PULSES. THESE PARAMETERS DIFFER FROM THE TREATMENT PARAMETERS SPECIFIED IN THE NEUROSTAR TMS THERAPY SYSTEM USER MANUAL (10HZ, 120%MT, 4 SEC ON/26 SEC OFF, 300 PULSES). AFTER THE INITIAL VISIT TO THE OPHTHALMOLOGIST THE TREATING PHYSICIAN AND THE OPHTHALMOLOGIST ASSESSED THE POSTERIOR VITREOUS DETACHMENT (PVD) AS NOT TMS RELATED, BUT AFTER THE SECOND OPHTHALMOLOGIST VISIT FOR THE RETINAL TEAR, THEY ASSESSED THE RETINAL TEAR AS TMS RELATED. THE NEURONETICS ASSESSMENT OF THE CAUSALITY IS THAT THE PVD WAS NOT TMS RELATED, WITH RISK FACTORS OF TREATED HYPERTENSION, DIABETES, AND EVIDENCE OF PRIOR PVD IN THE CONTRALATERAL EYE. THE RETINAL TEAR IS POSSIBLY TMS RELATED GIVEN THE TIMING IN RELATION TO THE TMS TREATMENT, BUT IS STILL CONFOUNDED BY THE RISK FACTORS MENTIONED ABOVE. THE DEVICE SERVICE RECORDS WERE OBTAINED AND REVIEWED. RESULTS OF THIS FOUND THAT THE DEVICE WAS FUNCTIONING AS INTENDED AND THERE WERE NO SIGNIFICANT OR ATYPICAL SERVICES PERFORMED TO THE SUBJECT DEVICE THAT WOULD HAVE AN AFFECT ON OR CAUSE THE MEDICAL EVENT.

    Description of Event or Problem · 1

    THE PT IS A (B)(6) MAN WITH MDD WHO HAD BEEN RECEIVING TMS OVER THE L-DLPC WITH STIMULATION PARAMETERS NOTED BELOW. HE NOTICED LEFT EYE FLOATERS SUDDENLY ON (B)(6), JUST AFTER TMS SESSION #26 ON THE LEFT SIDE. HE SAW AN OPHTHALMOLOGIST ON (B)(6). THE OPHTHALMOLOGY EXAM REVEALED A NEW POSTERIOR VITREOUS DETACHMENT (PVD) ON THE LEFT AND AN OLD VITREOUS DETACHMENT ON THE RIGHT. THERE WAS NO RETINAL HOLES OR TEARS. THE OPHTHALMOLOGIST IMPRESSION WAS THAT THE PVD WAS UNRELATED TO THE TMS. THE PT HAD A SINGLE TMS SESSION ON THE RIGHT DORSOLATERAL PFC ON (B)(6). THE OPHTHALMOLOGIST CLEARED PT TO RESUME LEFT-SIDED TMS ON (B)(6). AFTER THE 1ST OPHTHALMOLOGIST VISIT, THE TMS TREATING PHYSICIAN SPECIFICALLY LOOKED FOR EYE MOVEMENTS OR LID TWITCHING DURING THE TMS TREATMENTS AND ASKED THE PT IF HE NOTED ANY VISUAL CHANGE DURING THE TREATMENT SESSION BUT NEITHER HE NOR PT NOTED ANY MOVEMENTS. A SECOND WAVE OF ACUTE FLOATERS DEVELOPED ON (B)(6), AFTER TMS SESSION # 35. HE SAW THE OPHTHALMOLOGIST THAT AFTERNOON WHO IDENTIFIED A NEW LEFT RETINAL DETACHMENT WHICH RESPONDED TO LASER TREATMENT. THE LASER TREATMENT HAS BEEN HOLDING WELL SINCE (B)(6). THE PT HAS MADE A GOOD RECOVERY OF HIS VISUAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTAR TMS THERAPY SYSTEM TRANSCRANIAL MAGNETIC STIMULATOR OBP NEURONETICS, INC. 81-60000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention XANAX 1MG TID| TENORMIN 50MG QAM| ADDERALL 20MG BID| LICO3 600MG BID| SYNTHROID