Optune TFH9100 (REF TFH9100US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07290107982221), received between Nov 9, 2021 and Feb 8, 2024 — classified as 38 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 49-YEAR-OLD FEMALE WITH RECURRENT GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY (B)(6) 2023. ON JANUARY 13, 2024, NOVOCURE WAS INFORMED BY THE PATIENT THAT SHE FELL FORWARD WHILE USING THE BATHROOM, HITTING THE HEAD ON A DOORFRAME. PATIENT WAS SUBSEQUENTLY ADMITTED TO THE EMERGENCY DEPARTMENT. THE PATIENT DENIED LOSS OF CONSCIOUSNESS, HEADACHE AND BLURRED VISION. THE FALL RESULTED IN A 3 CM ABRASION WITH 0.25 CM SKIN LACERATION. THE PATIENT WAS WEARING OPTUNE GIO DEVICE DURING THE FALL. REPORTEDLY, ONE OF THE ELECTRODES BROKE AND CONTRIBUTED TO THE SKIN LACERATION. THE SKIN LACERATION WAS CLOSED WITH MEDICAL GLUE AND PATIENT DISCHARGED TO HOME IN STABLE CONDITION THE SAME DAY. ADDITIONALLY, PATIENT ENDORSED EXACERBATION OF CHRONIC LEFT SHOULDER PAIN, FOLLOWING THE FALL. THE PRESCRIBING PHYSICIAN WAS CONTACTED, BUT DID NOT PROVIDE A CAUSALITY ASSESSMENT.

  Patient problems: Laceration(s)

  MAUDE report 18666736 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, NOVOCURE RECEIVED THE REPLY REGARDING AN ANONYMOUS PATIENT SURVEY CONDUCTED IN THE UNITED STATES BY AN AGENCY ON BEHALF OF NOVOCURE. IN THE SURVEY, THE UNKNOWN PATIENT REPORTED THAT THEY EXPERIENCED A WOUND INFECTION AT THE SURGICAL RESECTION SITE. THE EVENT REQUIRED ADDITIONAL SURGERY THAT INCLUDED A "CLEAN-OUT" AND REMOVAL OF THE SKULL PLATE. DATE OF EVENT IS UNKNOWN. OPTUNE GIO THERAPY WAS DISCONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE, CUSTOMER CANNOT BE IDENTIFIED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18541194 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 68-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2020. ON (B)(6) 2023, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT WAS HOSPITALIZED ON AN UNSPECIFIED DATE DUE TO A FALL RELATED TO A MOBILITY ISSUE, UNRELATED TO OPTUNE THERAPY. AS A RESULT OF THE FALL, THE PATIENT HIT HIS HEAD AND SUSTAINED A SKIN LACERATION DESCRIBED AS A "CUT" THAT REQUIRED WOUND CARE. IT WAS CONFIRMED BY THE SPOUSE, THAT THE TRANSDUCER ARRAYS WERE LOCATED AT THE SITE OF THE HEAD INJURY. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. THE PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT.

  Patient problems: Laceration(s)

  MAUDE report 18533022 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 67-YEAR-OLD MALE PATIENT WITH GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON(B)(6) 2023. ON DECEMBER 13, 2023, NOVOCURE RECEIVED THE REPLY REGARDING A PATIENT SURVEY CONDUCTED BY AN AGENCY ON BEHALF OF NOVOCURE. IN THE SURVEY, THE PATIENT REPORTED THE TRANSDUCER ARRAY CORDS "CHOKED" HIM WHICH RESULTED IN A FALL THAT RESTRICTED HIS AIR SUPPLY. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM BY AMBULANCE. THE DATE OF EVENT OCCURRENCE IS UNKNOWN. NO FURTHER DETAILS OR CAUSALITY ASSESSMENT FROM THE PRESCRIBER IS AVAILABLE.

  Patient problems: Fall; Strangulation

  MAUDE report 18483502 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 60-YEAR-OLD MALE WITH GLIOBLASTOMA BEGAN OPTUNE GIO THERAPY ON (B)(6) 2022. ON AUGUST 18, 2023, NOVOCURE WAS INFORMED THAT THE PATIENT DEVELOPED A SORE ON THE TOP OF HIS HEAD. OPTUNE GIO THERAPY HAD BEEN TEMPORARILY DISCONTINUED ON (B)(6) 2023. ON OCTOBER 03, 2023, NOVOCURE RECEIVED A MEDICAL RECORD FROM AUGUST 2023, DOCUMENTING THAT PATIENT WILL BE REFERRED TO PLASTIC SURGERY FOR CLOSURE OF A WOUND INVOLVING THE VERTEX OF THE SCALP. THE PATIENT REPORTED ON OCTOBER 02, 2023, THAT HE RECENTLY HAD PLASTIC SURGERY AND PLANNED TO RESUME OPTUNE THERAPY ONCE HEALED. PER MEDICAL RECORD RECEIVED ON NOVEMBER 29, 2023, THE PATIENT EXPERIENCED A BIFRONTAL SCALP WOUND WITH PROGRESSIVE SCALP DEHISCENCE IN (B)(6) 2023, THAT REQUIRED A WOUND REVISION ON (B)(6) 2023. BEVACIZUMAB HAD BEEN HELD SINCE AUGUST 17, 2023. DURING A POST OPERATIVE VISIT ON (B)(6) 2023, THE PHYSICIAN NOTED THAT THE SCALP WOUND WAS HEALING WELL, AND THAT BEVACIZUMAB WOULD BE RESUMED. THE PATIENT NOTIFIED NOVOCURE ON NOVEMBER 14, 2023, THAT HE EXPERIENCED AN UNSPECIFIED INFECTION, HAD SEVERAL APPOINTMENTS, ONE OF WHICH WAS WITH INFECTIOUS DISEASE. ON (B)(6) 2023, THE PATIENT REPORTED HE HAD BEEN TRANSITIONED TO A REHABILITA

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 18363447 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 56-YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2023. DURING TREATMENT INITIATION THAT DAY, THE PATIENT REPORTED TO A NOVOCURE REPRESENTATIVE, THAT SHE EXPERIENCED AN ELECTRIC SENSATION DESCRIBED AS "ZAPPING". UPON RESTARTING THERAPY, IT WAS DISCOVERED THAT ONE OF THE TRANSDUCER ARRAY CABLES WAS NOT CONNECTED CORRECTLY TO THE CONNECTOR OF THE FIELD GENERATOR, WHICH RESULTED IN ANOTHER "ELECTRICAL SHOCK" SENSATION. THE PATIENT CONTINUED WITH OPTUNE THERAPY. ON OCTOBER 25, 2023, THE PATIENT'S CAREGIVER REPORTED THE PATIENT HAD EXPERIENCED A CONSISTENT HEADACHE IN THE REGION OF THE PREVIOUS ELECTRICAL SENSATION. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING TWO SEIZURES. THE PATIENT REMAINED HOSPITALIZED DUE TO THE SEIZURES AND HEADACHES THAT INITIATED ON THE EVENING OF (B)(6) 2023. ON (B)(6) 2023, THE HEALTHCARE PROVIDER (HCP) CONFIRMED THAT THE PATIENT HAD A HISTORY OF SEIZURES, DATING BACK TO 2015, THE MOST RECENT SEIZURE WAS ON THE DAY OF OPTUNE THERAPY START. THE PATIENT WAS PRESCRIBED LEVETIRACETAM 500MG BID, WHICH WAS INCREASED TO 750MG. THE PATIENT WAS DISCHARGED ON (B)(6

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 18225365 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 61-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6), 2023. NOVOCURE WAS INFORMED BY THE PATIENT'S SPOUSE ON (B)(6), 2023, THAT THE PATIENT FELL ON (B)(6), 2023, AND SUSTAINED A SKIN LACERATION ON THE UPPER RIGHT SIDE OF THE SCALP NEAR THE SURGICAL RESECTION SCAR THAT REQUIRED SEVERAL SUTURES. ON (B)(6), 2023, IT WAS CONFIRMED THAT THE PATIENT WAS ON OPTUNE THERAPY AT THE TIME OF THE FALL. THE PATIENT TRIPPED AND FELL FORWARD ONTO THE FLOOR, AND THE ARRAY CORDS GOT CAUGHT IN THE DOOR HANDLE AS SHE WAS FALLING. THE PATIENT WAS BROUGHT TO THE HOSPITAL EMERGENCY ROOM (ER) FOR THE TREATMENT OF THE SKIN LACERATION. A COMPUTED TOMOGRAPHY (CT) SCAN DONE IN THE ER SHOWED A HEMATOMA AND SWELLING UNDER THE SKIN IN THE LOCATION OF THE LACERATION THAT SUBSIDED AFTER BEING DISCHARGED HOME. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. THE PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT.

  Patient problems: Fall; Laceration(s)

  MAUDE report 17994731 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 64-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2023. NOVOCURE WAS INFORMED BY THE PATIENT'S SPOUSE ON (B)(6) 2023, THAT THE PATIENT'S SURGICAL RESECTION SITE WAS INFECTED AND SURGICAL INTERVENTION WAS NEEDED. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED ON (B)(6), 2023. ON (B)(6), 2023, THE SPOUSE REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE UNSPECIFIED COMPLICATIONS AND SUTURES REMAINED ON HER SCALP. THE INCISION SITE REPORTEDLY, OPENED AND UNSPECIFIED ANTIBIOTICS WERE PRESCRIBED FOR SIX DAYS. THE PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17842455 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 38 YEAR OLD FEMALE PATIENT WITH RIGHT FRONTAL ANAPLASTIC ASTROCYTOMA WHO GRADE IV BEGAN OPTUNE THERAPY ON (B)(6) 2022. ON (B)(6) 2023, NOVOCURE WAS INFORMED THAT THE PATIENT DEVELOPED A DEEP WOUND ON THE FRONT OF HER HEAD. THE HEALTHCARE PROVIDER (HCP) ADVISED THE PATIENT TO TEMPORARILY DISCONTINUE OPTUNE THERAPY TO FACILITATE WOUND HEALING AND ADVISED CONSULTATION WITH WOUND CARE SERVICES. ON (B)(6) 2023, DURING A PATIENT OFFICE VISIT, THE PATIENT PRESENTED WITH A SIGNIFICANT SCALP WOUND WITH EXPOSED CRANIAL BONE AND HARDWARE (LAST SURGICAL RESECTION (B)(6) 2022). IT WAS NOTED THAT EARLIER IN THE MONTH, THE PATIENT CONSULTED WITH NEUROSURGERY AND PLASTIC SURGERY DEPARTMENTS DUE TO POSSIBLE RADIATION-INDUCED EFFECTS ON THE SKIN INTEGRITY, POTENTIAL FOR INCREASED COMPLICATIONS FROM POTENTIAL RECONSTRUCTIVE WOUND PROCEDURES DUE TO PRIOR RADIOTHERAPY WERE NOTED. AN EXPEDITED REFERRAL TO WOUND CARE WAS ARRANGED AND PATIENT UNDERWENT WOUND DEBRIDEMENT ON AN UNSPECIFIED DATE. IT WAS DOCUMENTED IN THE RECORD, THAT PATIENT HAD POSSIBLE PROGRESSION VS RADIATION NECROSIS/INJURY UNDER CURRENT THERAPY REGIMEN. THUS, BEVACIZUMAB THERAPY WAS ANTICIPATED, BUT DUE TO WOUND COMPLICATION, IT WAS A

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17691034 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 40-YEAR-OLD MALE WITH A HIGH GRADE GLIOMA STARTED OPTUNE THERAPY ON (B)(6) 2023. NOVOCURE WAS INFORMED ON (B)(6) 2023, THAT THE PATIENT WAS HOSPITALIZED EARLIER THAT DAY DUE TO A SEIZURE. THE PATIENT NOTED HE HAD DISCONTINUED AN UNSPECIFIED SEIZURE MEDICATION THE MONTH PRIOR. THE PATIENT'S HEALTH CARE PROVIDER (HCP) WAS MADE AWARE AND OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2023, THE HCP REPORTED THAT THE PATIENT DID NOT HAVE A HISTORY OF SEIZURE. IN ADDITION, LEVETIRACETAM WAS PREVIOUSLY PRESCRIBED DURING HIS HOSPITAL ADMISSION IN (B)(6) 2023. IN THE EMERGENCY DEPARTMENT (ED) FOLLOWING THE SEIZURE THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) LEVETIRACETAM 1 GRAM AND UPON HOSPITAL ADMISSION 500MG IV EVERY 12 HOURS. LORAZEPAM WAS PRESCRIBED AS NEEDED FOR BREAKTHROUGH SEIZURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, ON ORAL LEVETIRACETAM 500MG BID, AND ADVISED TO RESUME DEXAMETHASONE AND FOLLOW UP WITH RADIATION ONCOLOGY AND NEUROSURGERY. THE HCP ASSESSED THAT THE EXACT CAUSE OF THE EVENT WAS UNKNOWN, THE EVENT MAY OR MAY NOT HAVE INVOLVED UNDERLYING DISEASE AND/OR OPTUNE THERAPY.

  Patient problems: Convulsion/Seizure

  MAUDE report 17445552 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66 YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2022. NOVOCURE WAS INFORMED ON (B)(6) 2023, THAT DURING A TRANSDUCER ARRAY CHANGE, THE PATIENT OBSERVED WHAT APPEARED AS EXPOSED CRANIAL HARDWARE ON THE SCALP IN THE LOCATION OF PREVIOUS SURGERY. AN IMAGE PROVIDED, REVEALED EXPOSED CRANIAL HARDWARE ON THE SURGICAL RESECTION SCAR (LAST SURGICAL RESECTION (B)(6) 2022). ON (B)(6), 2023, THE PATIENT'S CAREGIVER REPORTED THE PATIENT HAD SURGERY TO REMOVE FOUR PLATES AND A BONE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ACCORDING TO THE DISCHARGE SUMMARY PROVIDED BY THE PRESCRIBING PHYSICIAN, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023, FOR ELECTIVE SURGERY TO REMOVE EXPOSED CRANIAL HARDWARE OF THE RIGHT PARIETAL CRANIAL PLATES, IRRIGATION, AND DEBRIDEMENT OF THE RIGHT PARIETAL SCALP. INFECTIOUS DISEASE WAS CONSULTED AND ANTIBIOTICS (CEFTRIAXONE AND DAPTOMYCIN) WERE ADMINISTERED VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED, AND THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON (B)(6) 2023. ON (B)(6) 2023, THE PRESCRIBER ASSESSED THE EVENT AS RELATED TO OPTUNE THERAPY.

  Patient problems: Wound Dehiscence

  MAUDE report 17184923 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 67 YEAR OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2020. ON MAY 10, 2023 NOVOCURE RECEIVED INFORMATION THAT PATIENT REQUIRED WOUND DEBRIDEMENT OF INFECTED SKIN ULCERATIONS BENEATH THE INE TRANSDUCER ARRAYS. ACCORDING TO AVAILABLE MEDICAL RECORDS, PATIENT EXPERIENCED ULCERATIONS ON THE SCALP BENEATH THE TRANSDUCER ARRAYS STARTING IN (B)(6) 2022. THE PHYSICIAN ADVISED THE PATIENT TO TEMPORARILY DISCONTINUE OPTUNE THERAPY. THERAPY WAS RESUMED (B)(6) 2022. DURING A FOLLOW-UP VISIT ON (B)(6) 2023, PER PROGRESS NOTE, PATIENT HAD TEMPORARILY DISCONTINUED OPTUNE THERAPY FOR APPROXIMATELY THREE WEEKS DUE TO SKIN BREAKDOWN/IRRITATION. THE SCALP HEALED, AND THE PATIENT RESUMED OPTUNE THERAPY. HOWEVER, AFTER ONE WEEK, THE SKIN BREAKDOWN AND IRRITATION RECURRED. THE PHYSICIAN OBSERVED ULCERATIONS UNDER THE TRANSDUCER ARRAYS AND NOTED A PROGRESSIVE SCALP INFECTION WITH MALODOR. TREATMENT INCLUDED A TOPICAL ANTIBIOTIC (CLINDAMYCIN), ORAL (DOXYCYCLINE), AND A REFERRAL FOR OUTPATIENT HOME WOUND CARE. ACCORDING TO THE DEVICE LOG RECORDS, PATIENT TEMPORARILY DISCONTINUED OPTUNE THERAPY (B)(6) 2023. ON (B)(6) 2023, DURING A FOLLOW-UP OFFICE VISIT, THE PHYSICIAN

  Patient problems: Skin Infection; Ulcer

  MAUDE report 17082825 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2022. ON (B)(6) 2023, NOVOCURE WAS INFORMED BY THE SPOUSE THAT THE PATIENT WAS HOSPITALIZED THE PRIOR DAY DUE TO A FALL. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ACCORDING TO DISCHARGE SUMMARY PROVIDED BY THE TREATING PHYSICIAN ON (B)(6) 2023, THE PATIENT HAD BEEN WALKING AT HOME WITHOUT ASSIST OF A WALKER OR CANE WHEN HE TRIPPED AND FELL ON HIS RIGHT SIDE HITTING HIS FOREHEAD SUSTAINING A HEMATOMA ON THE FOREHEAD AS WELL AS SUPERFICIAL ABRASION TO THE FOREHEAD AND TO THE RIGHT ELBOW. THE PATIENT WAS ABLE TO GET UP WITH ASSISTANCE OF A FAMILY MEMBER AND WAS ABLE TO AMBULATE AFTER THE FALL. DURING ER EXAMINATION THE CAREGIVER REPORTED THAT PATIENT SEEMED MORE CONFUSED AFTER THE FALL, BUT DENIED LOSS OF CONSCIOUSNESS, NAUSEA, VOMITING OR SEIZURE-LIKE ACTIVITY. X-RAY OF THE RIGHT ELBOW REVEALED EVIDENCE OF A CLOSED FRACTURE OF DISTAL END OF THE RIGHT HUMERUS WITH JOINT EFFUSION OF THE RIGHT ELBOW. CERVICAL SPINE CT WAS WITHOUT ANY FINDINGS. HEAD CT CONFIRMED A SMALL ACUTE SUBARACHNOID HEMORRHAGE. NEUROSURGERY RECOMMENDED NO INTERVENTIONS. ORTHOPEDIC SURGERY RECOMMENDED NON-OPERATIVE MANAGEM

  Patient problems: Abrasion; Fall; Hematoma; Intracranial Hemorrhage; Limb Fracture

  MAUDE report 16945087 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 78-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2020. NOVOCURE WAS INFORMED ON (B)(6) 2023, THAT THE PATIENT HAD PLASTIC SURGERY SCHEDULED THE FOLLOWING DAY FOR A CHRONIC OPEN SORE ON THE SURGICAL RESECTION SITE (LAST SURGICAL RESECTION (B)(6) 2020). OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. IN THE PHOTO PROVIDED THERE APPEARED TO BE A WOUND DEHISCENCE ON THE SURGICAL RESECTION SCAR. ON (B)(6) 2023, THE PATIENT REPORTED THE SURGEON CLEARED HER TO RESUME OPTUNE THERAPY. AFTER SEVERAL ATTEMPTS OF CONTACT, THE PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16831464 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2021. NOVOCURE WAS INFORMED ON FEBRUARY 17, 2023, THAT THE PATIENT DEVELOPED AN OPEN AREA WITH EXPOSED CRANIAL HARDWARE AT THE SURGICAL RESECTION SITE (LAST SURGICAL RESECTION (B)(6) 2021). IN AVAILABLE MEDICAL RECORDS, THE PRESCRIBING PHYSICIAN NOTED ON (B)(6) 2023, AN OPEN WOUND WITH EXPOSED HARDWARE DEVELOPED IN (B)(6) 2023, HOWEVER THE PATIENT DID NOT REPORT TO THE PHYSICIAN AND CONTINUED TO PLACE ARRAYS OVER THE AFFECTED AREA. TREATMENT INCLUDED A TEN DAY COURSE OF ANTIBIOTICS (CEPHALEXIN 500MG QID). ON (B)(6) 2023, THE PATIENT MADE NOVOCURE AWARE SHE HAD RECURRENT SURGERY SCHEDULED FOR THAT WEEK. ON (B)(6) 2023, THE HEALTHCARE PROVIDER REPORTED, THE PATIENT EXPERIENCED DISEASE PROGRESSION, HAD EVIDENCE OF WOUND DEHISCENCE AND EXPOSED CRANIAL HARDWARE WITHOUT INFECTION. THE PATIENT UNDERWENT A LEFT CRANIOTOMY AND REMOVAL OF CRANIAL HARDWARE ON (B)(6) 2023. OPTUNE THERAPY WAS DISCONTINUED. PER THE PRESCRIBER, OPTUNE THERAPY CONTRIBUTED TO THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16762926 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 63 YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2020. THE PATIENT INFORMED NOVOCURE ON (B)(6) 2023, THAT SHE WENT TO URGENT CARE A FEW DAYS PRIOR DUE TO AN INFECTED AREA ON THE SCALP, WHERE SHE RECEIVED ANTIBIOTIC TREATMENT. THE HEALTH CARE PROVIDER (HCP) ADVISED TEMPORARILY DISCONTINUING OPTUNE THERAPY. PATIENT REPORTED, THAT ON (B)(6) 2023, SHE WENT TO THE EMERGENCY DEPARTMENT, DUE TO ANOTHER INFECTED AREA ON THE SCALP, WHICH MIGHT REQUIRE SURGICAL INTERVENTION. ON (B)(6) 2023, THE PATIENT REPORTED SHE WAS IN THE HOSPITAL AND SCHEDULED FOR SURGERY THE FOLLOWING DAY; PATIENT UNDERWENT SURGERY FOR WOUND WASHOUT (LAST SURGICAL RESECTION WAS (B)(6) 2019). IN THE IMAGES PROVIDED, THERE APPEARS TO BE AN OPENING AT THE SURGICAL RESECTION SITE WITH EXPOSED CRANIAL HARDWARE. PRESCRIBING PHYSICIAN CONFIRMED THAT THE PATIENT WAS HOSPITALIZED, UNDERWENT SURGERY FOR WOUND WASHOUT AND CLOSURE AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PRESCRIBING PHYSICIAN ASSESSED THE CAUSE OF THE EVENT AS POSSIBLY RELATED TO OPTUNE THERAPY. PATIENT TEMPORARILY DISCONTINUED OPTUNE THERAPY UPON PHYSICIAN'S INSTRUCTIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16673430 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 44 YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2021. DURING A NEURO-ONCOLOGY VISIT ON (B)(6) 2022, THE PRESCRIBING PHYSICIAN NOTED THE PATIENT DEVELOPED A 1 CM SCALP EROSION NEAR THE SURGICAL RESECTION INCISION (LAST SURGICAL RESECTION ON (B)(6) 2020). THE PATIENT REMAINED ON OPTUNE THERAPY. ON (B)(6) 2022, THE PATIENT PRESENTED TO NEURO-ONCOLOGY CLINIC VISIT, TO DISCUSS IF SURGICAL TREATMENT FOR AN OPEN SCALP WOUND IS REQUIRED, NO FURTHER DETAILS WERE AVAILABLE AT THAT TIME. PATIENT REMAINED ON OPTUNE THERAPY. ON (B)(6) 2023, IT WAS REPORTED THAT DUE TO A WOUND COMPLICATION, THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2023. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. PER THE HEALTHCARE PROVIDER THE PATIENT WAS PLANNED TO UNDERGO REPAIR OF A CHRONIC NON-HEALING RIGHT FRONTAL SCALP WOUND. ON (B)(6) 2023, THE SPOUSE REPORTED A SMALL PORTION OF CRANIAL BONE WAS SURGICALLY REMOVED ON THE RIGHT SIDE OF THE HEAD AND THE PATIENT WAS STILL RECOVERING. OPTUNE THERAPY WOULD BE RESUMED ONCE CLEARED BY NEUROSURGERY. NO CAUSALITY ASSESSMENT WAS PROVIDED BY THE PRESCRIBING PHYSICIAN.

  Patient problems: Wound Dehiscence

  MAUDE report 16378287 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 52 YEAR OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2022. ON (B)(6) 2023, NOVOCURE WAS INFORMED THAT THE PATIENT WAS SCHEDULED FOR AN UNSPECIFIED SURGERY ON (B)(6) 2023. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2023, THE PRESCRIBING PHYSICIAN REPORTED THE PATIENT EXPERIENCED WORSENING EXPRESSIVE APHASIA AND ON AN UNSPECIFIED DATE, UNDERWENT A CRANIOTOMY AND RESECTION. ON (B)(6) 2022, BRAIN MRI AND RCBV (RELATIVE CEREBRAL BLOOD VOLUME), DEMONSTRATED ENHANCEMENT ALONG THE SURGICAL CAVITY COMPARED TO PRIOR MRI ON (B)(6) 2022. SUSPECTED COMBINATION OF TREATMENT EFFECT FROM RADIATION AND POTENTIAL TUMOR PROGRESSION. THE PHYSICIAN ASSESSED THE CAUSE OF THE EVENT TO BE A COMBINATION OF FACTORS INCLUDING UNDERLYING DISEASE, DISEASE/TUMOR PROGRESSION, AND OPTUNE THERAPY.

  Patient problems: Speech Disorder

  MAUDE report 16284973 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 65 YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2022. ON (B)(6) 2022, NOVOCURE WAS INFORMED THE PATIENT EXPERIENCED A SORE ON THE SCALP WITH EXPOSED CRANIAL HARDWARE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2023, THE SPOUSE REPORTED THE PATIENT UNDERWENT A CRANIOTOMY ON THAT DAY, NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2023, THE PRESCRIBING PHYSICIAN REPORTED THE PATIENT WAS NOT HOSPITALIZED. PHYSICAL EXAMINATION ON AN UNSPECIFIED DATE, SHOWED A SMALL SUB CENTIMETER AREA OF SKIN DEHISCENCE AT THE INCISION SITE OF HER PRIOR CRANIOTOMY (LAST SURGICAL RESECTION (B)(6) 2021), WHICH WAS A VERY THIN PORTION OF SKIN APPROXIMATELY 3 MM WITH EXPOSED HARDWARE (SURGICAL PLATE). THE PHYSICIAN SENT THE PATIENT TO NEUROSURGERY TO BE EVALUATED. OPTUNE THERAPY WAS TEMPORARILY INTERRUPTED PER PHYSICIAN ADVICE. THE PHYSICIAN WAS NOT AWARE OF THE RECOMMENDATIONS OF NEUROSURGERY, THUS CANNOT PROVIDE FURTHER DETAILS. ON (B)(6)3, IT WAS REPORTED THE PATIENT UNDERWENT SURGERY APPROXIMATELY TWO WEEKS PRIOR AND SUTURE REMOVAL PLANNED FOR THE FOLLOWING WEEK. A CAUSALITY ASSESSMENT TO THE EVENT WAS NOT PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 16237314 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 12, 2022, NOVOCURE RECEIVED THE REPLY OF A PATIENT IN REGARDS TO A PATIENT SURVEY CONDUCTED BY AN AGENCY ON BEHALF OF NOVOCURE. PATIENT IS A 67 YEAR OLD MALE, WHO BEGAN OPTUNE THERAPY ON (B)(6), 2022. IN THE SURVEY, THE PATIENT REPORTED THE DEVICE HINDERED HIS MOBILITY AND THE BATTERY PACK WAS VERY HEAVY. REPORTEDLY, HE DROPPED THE DEVICE ON HIS FOOT, WHICH CAUSED A MAJOR INJURY THAT REQUIRED SURGERY. DATE OF EVENT OCCURRENCE IS UNKNOWN. AFTER SEVERAL ATTEMPTS OF CONTACT, PRESCRIBING PHYSICIAN DID NOT REPLY. NO FURTHER DETAILS AND NO CAUSALITY ASSESSMENT FROM THE PRESCRIBER IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16152546 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 68-YEAR OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2022. NOVOCURE RECEIVED A REPORT ON (B)(6) 2022, THAT THE PATIENT EXPERIENCED A SEIZURE ON (B)(6) 2022, THAT REQUIRED HOSPITALIZATION. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT PRESENTED WITH ALTERED MENTAL STATUS AND UNABLE TO CONFIRM MEDICAL HISTORY. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) ANTI-SEIZURE MEDICATION (LACOSAMIDE 200 MG, LEVETIRACETAM 2,000 MG). CONTINUOUS ELECTROENCEPHALOGRAPHY (EEG) CONFIRMED ABNORMAL FINDINGS CONSISTENT WITH SEIZURE ACTIVITY. ON (B)(6) 2022, THE PRESCRIBING PHYSICIAN REPORTED THE PATIENT DID NOT HAVE A HISTORY OF SEIZURES. THE BRAIN MRI DID NOT SHOW EVIDENCE OF DISEASE PROGRESSION AND EEG SHOWED ABNORMAL ACTIVITY CONFIRMING SEIZURE. REPORTEDLY, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION AND PRESCRIBED LEVETIRACETAM. THE PHYSICIAN NOTED THE PATIENT WAS PRESCRIBED TEMOZOLOMIDE AND UNSURE IF THE SEIZURE WAS RELATED TO OPTUNE THERAPY OR TEMOZOLOMIDE.

  Patient problems: Convulsion/Seizure

  MAUDE report 15932571 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2022. ON (B)(6) 2022, NOVOCURE RECEIVED A REPORT THAT THE PATIENT WAS HOSPITALIZED AND SCHEDULED FOR AN UNSPECIFIED SURGERY LATER THAT DAY. PER HOSPITAL SUMMARY PROVIDED, ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION OF YELLOW DRAINAGE FROM A HEAD WOUND. WOUND CULTURES GREW SERRATIA AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS (CEFEPIME 2 GRAMS EVERY 12 HOURS). ON (B)(6) 2022, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ALTERED MENTAL STATUS, FEVER (102F), LETHARGY AND INCISIONAL WOUND BREAKDOWN WITH PURULENT DISCHARGE (LAST SURGICAL RESECTION (B)(6) 2021). THE PATIENT UNDERWENT A RIGHT FRONTAL CRANIECTOMY AND EVACUATION OF INTRACEREBRAL ABSCESS AND REMOVAL OF ARTIFICIAL CRANIAL FLAP, WITH PLASTIC SURGERY ASSISTING WITH CLOSURE. THERE WERE NO COMPLICATIONS. SUPERFICIAL AND DEEP WOUND CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS. A LEFT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED FOR LONG-TERM ANTIBIOTIC THERAPY (VANCOMYCIN AND NAFCILLIN).

  Patient problems: Abscess; Post Operative Wound Infection

  MAUDE report 15901441 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 57-YEAR OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT A NOVOCURE CARE COORDINATOR THAT WHILE HE WAS WALKING IN HIS HOUSE, HE SUDDENLY FELT AN "ELECTRICAL SURGE" INSIDE AND ON THE SURFACE OF HIS HEAD. THE FEELING RAN DOWN HIS HEAD INTO HIS TEETH, ALMOST CAUSING HIM TO LOSE CONSCIOUSNESS. AFTER THE EVENT, THE PATIENT COULD STILL FEEL A TINGLING SENSATION IN HIS HEAD AND HAD AN INTENSE HEADACHE. THE PATIENT WAS REPORTEDLY NO LONGER COMFORTABLE USING THAT PARTICULAR DEVICE AND WAS GIVEN A REPLACEMENT. ON (B)(6) 2022, THE PATIENT REPORTED TO A NOVOCURE DEVICE SUPPORT SPECIALIST (DSS) THAT HE HAD NOT USED OPTUNE SINCE THE INCIDENT MENTIONED ABOVE. ADDITIONALLY, THE PATIENT WAS STILL EXPERIENCING SEVERE HEADACHES, SHORT-TERM MEMORY LOSS, HIGH BLOOD PRESSURE, RIGHT FOOT DRAG, FRONT TEETH SENSITIVITY AND FATIGUE. ON (B)(6) 2022, THE PATIENT REPORTED TO A NOVOCURE DSS FURTHER SIDE EFFECTS FROM THE INCIDENT ON (B)(6) 2022. ACCORDING TO THE PATIENT, HE NOW HAD A RINGING SOUND IN HIS RIGHT. THE PATIENT REITERATED THAT HE WAS EXPERIENCING EXTREME TEETH SENSITIVITY, SEVERE HEADACHES, EXTREME FATIGUE AND TROUBLE WALKIN

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Distress; Electric Shock; Fatigue; Headache; High Blood Pressure/ Hypertension; Memory Loss/Impairment; Sensitivity of Teeth; Speech Disorder; Tinnitus

  MAUDE report 15779809 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 61-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE THERAPY ON (B)(6) 2022. PATIENT UNDERWENT RESECTION SURGERY OF GBM RECURRENCE SCHEDULED ON (B)(6) 2022. (B)(4) THERAPY WAS TEMPORARILY DISCONTINUED. (B)(4) THERAPY WAS RESUMED ON (B)(6) 2022, ARRAYS WERE PLACED TO AVOID THE SURGICAL SCAR AS MUCH AS POSSIBLE. ON (B)(6) 2022, THE PATIENT INFORMED NOVOCURE THAT SHE WAS SCHEDULED FOR SURGERY ON (B)(6) 2022, TO CLOSE A NON-HEALING WOUND. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED STARTING (B)(6) 2022. PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS, WITHOUT RESPONSE.

  Patient problems: Wound Dehiscence

  MAUDE report 15373942 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOVOCURE RECEIVED A REPORT THAT THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2022, DUE TO A SEIZURE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT EXPERIENCED AN ACUTE ONSET OF SEIZURE LIKE ACTIVITY WITH RIGHT SIDED WEAKNESS. THE PATIENT'S FAMILY CALLED EMERGENCY MEDICAL SERVICES AND UPON ARRIVAL, THE PATIENT EXPERIENCED ANOTHER 30 SECOND EPISODE OF FLACCIDITY ON THE RIGHT SIDE WITH INCOHERENT SPEECH AND POSTICTAL PHASE. THE PATIENT DID NOT HAVE A HISTORY OF SEIZURES AND WAS ADMITTED FOR OBSERVATION. THE PATIENT'S NEURO-ONCOLOGIST RECOMMENDED INITIATION OF ANTI-SEIZURE MEDICATION (LEVETIRACETAM 500 MG BID). THE PATIENT HAD NO FURTHER SEIZURE LIKE ACTIVITY WHILE HOSPITALIZED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED HOME. PER THE PRESCRIBING PHYSICIAN, THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO RADIATION EFFECT VERSUS TUMOR PROGRESSION. HE ADDITIONALLY STATED, HE COULD NOT ENTIRELY EXCLUDE A CONTRIBUTION OF OPTUNE TO THE EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 15114651 ↗