BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTTF-100A

    MDR report key: 3940210 · Received June 20, 2014

    Report

    Report Number
    3009453079-2014-00040
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    NOVOCURE, LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL # (B)(4). NOVOCURE CONCURS WITH THE TREATING PHYSICIAN THAT THE EVENT WAS RELATED TO ATHEROSCLEROSIS EXACERBATED IN THE SETTING OF PRIOR RADIATION TREATMENT. EVENT WAS NOT RELATED TO NOVOTTF THERAPY. CEREBRAL ARTERY INFARCT WAS NOT REPORTED IN THE PIVOTAL PHASE III RECURRENT GBM TRAIL. IN THE COMMERICAL PROGRAM, THERE HAS BEEN 1 PRIOR REPORT OF CEREBRAL ARTERY INFARCT, WHICH WAS NOT RELATED TO NOVOTTF THERAPY, RISK FACTORS FOR STROKE IN THIS PATIENT INCLUDE: PRIOR RADIOTHERAPY AND MULTIPLE TUMOR RESECTION SURGERIES, HIGH CHOLESTEROL, OBSTRUCTIVE SLEEP APNEA AND AGE.

    Description of Event or Problem · 1

    ON (B)(6), 2014 NOVOCURE WAS INFORMED BY THE SPOUSE THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO A STROKE. PER HOSPITAL SUMMARY PROVIDED BY PRESCRIBING SITE, ON (B)(6), 2014 THE PATIENT NOTED LEFT HAND LIMITED GRIP STRENGTH AND LEFT SIDE LIMITED STRENGTH. PATIENT ALSO COMPLAINED OF SLURRED SPEECH AND DIFFICULTY GETTING DRESSED. ON (B)(6), 2014, PATIENT PRESENTED TO HOSPITAL WITH WORSENED LEFT HAND GRIP STRENGTH, LEFT SIDED WEAKNESS AND DIFFICULTY SWALLOWING. NOVOTTF THERAPY WAS DISCONTINUED UPON ADMISSION. STROKE WORK-UP SHOWED UNREMARKABLE COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA), NORMAL ALC, NORMAL TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND SLIGHTLY ELEVATED LDL. FINAL DIAGNOSIS WAS ACUTE RIGHT PUTAMEN/CORONA RADIATA ISCHEMIC INFARCT SECONDARY TO ATHEROSCLEROSIS EXACERBATED IN THE SETTING OF PRIOR RADIATION TREATMENT. ASPIRIN WAS STARTED ON ADMISSION AND WILL BE CONTINUED. STATIN THERAPY WAS HELD GIVEN ONGOING GLIOMA TREATMENT. ON (B)(6), 2014, PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. PATIENT PLANNED TO RESTART NOVOTFF THERAPY UPON DISCHARGE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362457 NOVOTTF-100A NZK NOVOCURE, LTD TFH-9000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization ASCORBIC ACID| ACETAMINOPHEN| OXYBUTYNIN| PHENOBARBITAL| CHOLECALCIFEROL| ASPIRIN| MELATONIN| CITALOPRAM