Optune THF9000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07290107980401), received between Sep 21, 2015 and Jul 8, 2019 — classified as 17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2017. PER CLINIC NOTES, ON (B)(6) 2019, PATIENT WAS NOTED TO HAVE PURULENT DRAINAGE FROM THE CRANIOTOMY WOUND (LAST RESECTION (B)(6) 2016). WOUND CULTURE WAS (B)(6) FOR (B)(6). MEDICAL HISTORY WAS NOTED TO BE SIGNIFICANT FOR RECURRENT SUPERFICIAL SCALP INFECTIONS. PATIENT WAS STARTED ON ANTIBIOTICS AND A BONE SCAN WAS PLANNED TO ASSESS FOR OSTEOMYELITIS (NO FURTHER INFORMATION PROVIDED). SURGERY WAS PLANNED FOR BONE REVISION AND SKIN GRAFT. OPTUNE WAS DISCONTINUED. ON (B)(6) 2019, THE PATIENT REPORTED TO NOVOCURE THAT HE HAD UNDERGONE WOUND REVISION SURGERY 4 WEEKS PRIOR (ON APPROXIMATELY (B)(6) 2019). ON (B)(6) 2019, PATIENT REPORTED THAT THE SUTURES WERE REMOVED ON (B)(6) 2019. THE PATIENT NOTED THAT THERE WAS STILL SOME DRAINAGE AND BLEEDING FROM THE WOUND AND HE WAS EXPERIENCING DISCOMFORT AND PAIN ASSOCIATED WITH THE SCAR. THE PATIENT STATED THAT SORES FROM OPTUNE HAD ADVERSELY AFFECTED HIS SCALP. PATIENT HAD BEEN INSTRUCTED TO ALLOW ADDITIONAL TIME FOR THE SURGICAL WOUND TO FULLY HEAL BEFORE RESUMING OPTUNE THERAPY. PER PRESCRIBING PHYSICIAN, THE EVENT WAS UNRELATED TO OPTUNE THERA

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 8767318 ↗
• InjuryJul 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA ON BEVACIZUMAB PLUS NIVOLUMAB BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016, PATIENT DEVELOPED A SKIN REACTION (DESCRIBED AS "SORES") AND TEMPORARILY DISCONTINUED OPTUNE THERAPY. PATIENT WAS NOT HOSPITALIZED OR MEDICALLY TREATED FOR THE EVENT. ON (B)(6) 2016, THE PATIENT RESUMED OPTUNE THERAPY. ON JULY 7, 2015, NOVOCURE WAS INFORMED BY THE PRESCRIBING SITE NURSE THAT THE PATIENT HAD EXPERIENCED SKIN EROSION NEAR THE AREA OF HER VENTRICULOPERITONEAL (VP) SHUNT (INSERTED ON (B)(6) 2015). OPTUNE THERAPY WAS DISCONTINUED. VP SHUNT WAS REMOVED ON (B)(6) 2016. WOUND AND BLOOD CULTURES WERE NEGATIVE. PATIENT WAS SEEN AT THE PRESCRIBER'S CLINIC ON (B)(6) 2016 AND THE SURGICAL SITE WAS HEALING. PRESCRIBER ASSESSED THE EVENT AS RELATED TO OPTUNE THERAPY.

  Patient problems: Skin Erosion

  MAUDE report 5808355 ↗
• InjuryJun 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT REPORTED TO THEIR PRESCRIBER THAT THEY WERE EXPERIENCING PAIN AND ERYTHEMA AT THE CRANIOTOMY INCISION SITE (RESECTION PERFORMED ON (B)(6) 2016). PRESCRIBER NOTED THE LEFT CRANIAL INCISION HAD A QUARTER INCH OPENING WITH MINIMAL ERYTHEMA. THERE WAS NO ACTIVE DRAINAGE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2016 THE PATIENT UNDERWENT WOUND DEBRIDEMENT, REMOVAL OF INFECTED BONE FLAP, AND SUBGALEAL FLUID COLLECTION DRAIN PLACED. SURGICAL CULTURE WAS POSITIVE FOR (B)(6). THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016 ON INTRAVENOUS CEFAZOLIN (2 G EVERY 8 HOURS). AT A POSTOPERATIVE FOLLOW-UP APPOINTMENT ON (B)(6) 2016, THE PATIENT DENIED TENDERNESS, DRAINAGE, ERYTHEMA OR WARMTH WITH THE WOUND. SUTURES WERE REMOVED AND INCISION WAS WELL APPROXIMATED WITH THE EXCEPTION OF A SMALL AREA ABOVE THE CRANIECTOMY DEFECT. THERE WAS NO EVIDENCE OF ERYTHEMA, INFECTION OR DRAINAGE. THERE WAS NO OPENING AT THE SITE. PRESCRIBER ADVISED PATIENT TO RESTART OPTUNE THERAPY, AVOIDING THE AREA OF THE SCALP INCISION. THE PRESCRIBING PHYSICIAN STATED THAT THE EVENT WAS RELATED TO CONCOMITANT BEVA

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 5695589 ↗
• InjuryMay 4, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016 NOVOCURE WAS INFORMED THAT THE PATIENT HAD BEEN HOSPITALIZED (B)(6) 2016 DUE TO A NEW ONSET SEIZURE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED DURING THIS TIME PERIOD. ON (B)(6) 2016 THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE PATIENT HAD PRESENTED WITH TUMOR PROGRESSION AND WAS NOT ON ANTICONVULSANTS AT THE TIME OF THE SEIZURE. NO ADDITIONAL INFORMATION WAS PROVIDED. PHYSICIAN STATED THAT THE SEIZURE WAS PROBABLY RELATED TO UNDERLYING DISEASE, HOWEVER A RELATIONSHIP WITH OPTUNE THERAPY COULD NOT BE RULED OUT.

  Patient problems: Seizures

  MAUDE report 5630509 ↗
• InjuryApr 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016, PATIENT'S DAUGHTER REPORTED PATIENT WAS HOSPITALIZED DUE TO AN OPEN WOUND WITH DEHISCENCE AT THE SITE OF THE PATIENT'S PREVIOUS SURGICAL RESECTION SCAR (RESECTION ON (B)(6) 2016). PER DISCHARGE SUMMARY, PATIENT WAS ADMITTED (B)(6) 2016 FOR WOUND DEHISCENCE AND SUSPECTED ABSCESS OF THE BRAIN. PATIENT UNDERWENT REPEAT CRANIOTOMY AND DRAINAGE OF BRAIN ABSCESS X2 ON (B)(6) 2016, RESPECTIVELY. DEEP WOUND CULTURES WERE POSITIVE FOR MORAXELLA CATARRHALIS, BETA LACTAMASE, AND PROPIONIBACTERIUM ACNES. BRAIN MRI CONDUCTED ON (B)(6) 2016 WAS STABLE WHEN COMPARED TO PREVIOUS MRI CONDUCTED ON (B)(6) 2016. PATIENT WENT ON A 56 DAY COURSE ANTIBIOTICS (CEFTRIAXONE) TO TREAT INFECTION AND WAS DISCHARGED IN GOOD CONDITION TO A SKILLED NURSING FACILITY FOR SHORT TERM REHABILITATION ON (B)(6) 2016. PER PRESCRIBING PHYSICIAN, THE EVENTS WERE CAUSED BY SKIN BREAKDOWN AND WOUND DEHISCENCE DUE TO CONCOMITANT BEVACIZUMAB USAGE. PHYSICIAN STATED THE EVENTS WERE UNLIKELY CAUSED BY OPTUNE THERAPY.

  Patient problems: Abscess; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 5621130 ↗
• InjuryDec 17, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015, NOVOCURE WAS INFORMED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD BEEN HOSPITALIZED FOLLOWING A SEIZURE. ON (B)(6) 2015 THE PRESCRIBING PHYSICIAN CONFIRMED THAT ON (B)(6) 2015, THE PATIENT HAD BEEN FOUND BY A FAMILY MEMBER WITH NEW ONSET GENERALIZED CONVULSIVE ACTIVITY WHICH LASTED 2-3 MINUTES AND RESOLVED. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 AND STARTED ON LEVETIRACETAM. OPTUNE THERAPY WAS DISCONTINUED ON ADMISSION. PATIENT WAS DISCHARGED (B)(6) 2015. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE PATIENT RESTARTED OPTUNE THERAPY. THE PATIENT DID NOT HAVE A HISTORY OF SEIZURES AND WAS NOT ON ANTI-SEIZURE MEDICATION AT THE TIME OF THE EVENT.

  Patient problems: Seizures, Grand-Mal

  MAUDE report 5307796 ↗
• InjuryDec 16, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015 THE CAREGIVER REPORTED THAT THE PATIENT HAD TEMPORARILY DISCONTINUED OPTUNE THERAPY FOR APPROXIMATELY A MONTH PRIOR DUE TO NEW ONSET SEIZURES AND HAD BEEN ADMITTED TO A REHABILITATION FACILITY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2015 WITH FOCAL STATUS EPILEPTICUS CLINICALLY. PATIENT WAS ADMITTED TO THE ICU. EEG CONFIRMED SIGNIFICANT RIGHT HEMISPHERE STATUS EPILEPTICUS. THE PATIENT WAS INTUBATED AND STARTED ON INTRAVENOUS LEVETIRACETAM BOLUS AS WELL AS FOSPHENYTOIN AND LACOSAMIDE. BRAIN MRI SHOWED SUBSTANTIAL IMPROVEMENT IN THE RIGHT HEMISPHERIC TUMOR WITH MUCH LESS ENHANCEMENT, MASS EFFECT AND EDEMA COMPARED TO PREVIOUS (PERFORMED ON (B)(6) 2015). ON (B)(6) 2015, EEG WAS ABNORMAL, SUGGESTING SEVERE ENCEPHALOPATHY POSSIBLY DUE TO MEDICAL EFFECT. LEFT TEMPORAL SHARP WAVES PLACED PATIENT AT RISK FOR FOCAL SECONDARY GENERALIZED SEIZURES. ON (B)(6) 2015, EEG WAS GROSSLY ABNORMAL WITH DIFFUSE SLOW BACKGROUND SUGGESTIVE OF SEVERE ENCEPHALOPATHY. ON (B)(6) 2015 PROLONGED VIDEO EEG WAS ABNORMAL WITH SLOW BACKGROUND AND FREQUENT RIGHT TEMPORAL SHARP WAVES INDICATIVE OF SEVER

  Patient problems: Seizures, Focal

  MAUDE report 5302141 ↗
• InjuryDec 3, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015, PATIENT PRESENTED TO AN OUTSIDE AREA HOSPITAL WITH SHORTNESS OF BREATH. CHEST X-RAY SHOWED RIGHT LOBE INFILTRATE CONCERNING FOR PNEUMONIA. PATIENT WAS ADMITTED FOR THE TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA WITH CEFTRIAXONE AND LEVOFLOXACIN. OXYGENATION CONTINUED TO WORSEN AND CHEST CT REVEALED NEW ONSET SADDLE PULMONARY EMBOLUS (PE). PATIENT WAS TREATED WITH HEPARIN INFUSION AND TRANSFERRED TO THE INTENSIVE CARE UNIT AT PRESCRIBING SITE FOR FURTHER CARE. UPON PRESENTATION, PATIENT WAS EXPERIENCING SHORTNESS OF BREATH DUE TO HYPOXEMIC RESPIRATORY FAILURE SECONDARY TO PE AND PNEUMONIA. PATIENT WAS STARTED ON CEFTRIAXONE AND AZITHROMYCIN FOR TREATMENT OF PNEUMONIA AND CONTINUED ON HEPARIN DRIP FOR ANTICOAGULATION. DOPPLER ULTRASOUND SHOWED DEEP VEIN THROMBOSIS (DVT) IN RIGHT LOWER EXTREMITY. ECHOCARDIOGRAM SHOWED EJECTION FRACTION (EF) 60-65% WITH MILD DILATION OF RIGHT VENTRICLE. PATIENT WAS THROMBOCYTOPENIC THROUGHOUT COURSE. PATIENT TRANSITIONED TO ENOXAPARIN AND PLATELET LEVEL INCREASED. ON (B)(6) 2015, PATIENT DEEMED MEDICALLY STABLE AND WAS TRANSFERRED FROM THE ICU TO HEMATOLOGY/ON

  Patient problems: Pulmonary Embolism

  MAUDE report 5263592 ↗
• InjuryNov 13, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015 AS PART OF THE INVESTIGATOR SPONSORED TRIAL "PROPOSED PILOT STUDY OF COMBINED NOVOTTF-100A, BEVACIZUMAB, AND HYPO-FRACTIONATED STEREOTACTIC IRRADIATION FOR BEVACIZUMAB-NAIVE, RECURRENT GLIOBLASTOMA". ON (B)(6) 2015, NOVOCURE WAS INFORMED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO GRADE 3 SEIZURES. PATIENT DISCONTINUED OPTUNE THERAPY UPON ADMISSION. PATIENT HAD A HISTORY OF SEIZURES AND WAS ON ANTI-SEIZURE MEDICATION (LEVETIRACETAM) AT THE TIME OF THE EVENT. PATIENT PLANNED TO TRANSITION TO (B)(6) DUE TO DISEASE PROGRESSION. PER PRESCRIBING SITE RESEARCH COORDINATOR, THE SEIZURE WAS PROBABLY RELATED TO UNDERLYING DISEASE AND POSSIBLY RELATED TO OPTUNE THERAPY. ON (B)(6) 2015 NOVOCURE WAS INFORMED THAT THE PATIENT HAD DIED ON (B)(6) 2015. PRESCRIBING PHYSICIAN STATED THE CAUSE OF DEATH WAS UNDERLYING GLIOBLASTOMA AND WAS UNRELATED TO OPTUNE THERAPY.

  Patient problems: Seizures

  MAUDE report 5222671 ↗
• InjuryNov 12, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT HAD SWELLING AT THE SURGICAL RESECTION SITE (SURGERY PERFORMED ON (B)(6) 2015). ON (B)(6) 2015 PATIENT PRESENTED TO THE NEURO-ONCOLOGY CLINIC WITH EXUDATIVE DRAINAGE FROM THE PRIOR CRANIOTOMY INCISION. OPTUNE THERAPY WAS DISCONTINUED UPON ADMISSION. PATIENT UNDERWENT WOUND AND EPIDURAL WASHOUT, CRANIECTOMY, AND BONE EDGE DEBRIDEMENT THAT SAME DAY. PATHOLOGY TESTED POSITIVE FOR PROPIONIBACTERIUM ACNES. PATIENT WAS STARTED ON VANCOMYCIN 750 MG Q12 HOUR. ON (B)(6) 2014, PICC LINE WAS PLACED. ON (B)(6) 2015, PATIENT WAS DISCHARGED HOME ON VANCOMYCIN VIA PICC LINE AND ADVISED TO WEAR A HELMET WHILE AMBULATING DUE TO MISSING BONE FLAP. ON AN UNKNOWN DATE, PATIENT WAS SWITCHED TO CEFTRIAXONE 2GRAMS Q12 HOUR. ON (B)(6) 2014 THE PATIENT PRESENTED TO THE HOSPITAL IN PARTIAL SEIZURE STATUS (NEW ONSET) ON ADMISSION, WITH CONTINUED RHYTHMIC SHAKING OF LEFT ARM AND LEG, AND THEN ABDOMINAL SHAKING. THE PATIENT WAS ADMINISTERED CLONAZEPAM (0.5 MG TID), LACOSAMIDE (100 MG BID) AND LEVETIRACETAM (1000 MG BID) WITH NO FURTHER SEIZURE ACTIVITY. IN-PATIEN

  Patient problems: Post Operative Wound Infection; Seizures, Focal

  MAUDE report 5220138 ↗
• InjuryNov 9, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015 NOVOCURE WAS INFORMED THAT ON (B)(6) 2015 THE PATIENT WAS HOSPITALIZED DUE TO A FALL AND REQUIRED SUTURES FOR A HEAD WOUND SUSTAINED FROM MECHANICAL IMPACT WITH AN OPTUNE ARRAY DISK. IT WAS UNKNOWN IF THERE WAS LOSS OF CONSCIOUSNESS OR SEIZURE ACTIVITY ASSOCIATED WITH THE FALL. THE PATIENT WAS EXPERIENCING DISEASE PROGRESSION AT THE TIME OF THE EVENT. PER PRESCRIBING PHYSICIAN, THE FALL WAS NOT RELATED TO OPTUNE THERAPY.

  Patient problems: Fall; Laceration(s)

  MAUDE report 5210679 ↗
• InjuryNov 5, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED ANAPLASTIC ASTROCYTOMA BEGAN OPTUNE THERAPY ON (B)(6), 2015. ON (B)(6), 2015, NOVOCURE WAS INFORMED THAT ON (B)(6), 2015 THE PATIENT HAD BEEN HOSPITALIZED DUE TO NEW ONSET SEIZURE. THE PATIENT HAD EXPERIENCED THREE SIX MINUTE SEIZURES WITHOUT RETURN TO BASELINE PRIOR TO PRESENTATION. MRI DID NOT SHOW ANY NEW AREAS OF ENHANCEMENT OR INCREASED PERFUSION SIGNAL, COMPARED TO PREVIOUS (ON (B)(6) 2015). ANTI-SEIZURE MEDICATION (LEVETIRACETAM) WAS INCREASED HOWEVER, THE PATIENT HAD TWO ADDITIONAL SEIZURES ON (B)(6), 2015. THE PATIENT WAS LOADED WITH PHENYTOIN BUT DEVELOPED A DRUG REACTION (ITCHING) AND WAS SWITCHED TO LACOSAMIDE. THE PATIENT DID NOT EXPERIENCE FURTHER SEIZURES DURING THE HOSPITAL STAY BUT REMAINED TIRED AND SIGNIFICANTLY WEAKER THAN BEFORE THE SEIZURES. WEAKNESS WAS ATTRIBUTED TO SEIZURES AND STEROID (DEXAMETHASONE) MYOPATHY. SEIZURE PRECAUTIONS WERE CONTINUED DURING THE HOSPITAL STAY. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL HOSPITALIZED WITH PLANS TO DISCHARGE HOME WITH OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR ONGOING WEAKNESS. PER THE PRESCRIBING PHYSICIAN, THE SEIZURES WERE RELATED TO DISEASE PROGRESSION AND WERE NOT RELATED T

  Patient problems: Seizures

  MAUDE report 5205296 ↗
• InjuryOct 19, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015, DURING A ROUTINE OFFICE VISIT, THE PRESCRIBING PHYSICIAN NOTED A SMALL, NON-OPEN, TENDER AREA ON THE BACK OF THE PATIENT'S SCALP IN THE AREA WHERE THE PLASTIC PIECE OF THE ARRAY WIRE TOUCHED THE SCALP. OPTUNE WAS DISCONTINUED. THE FOLLOWING DAY, THE SORENESS ESCALATED TO SERIOUS PAIN AND THE AREA CONTINUED TO GROW. ON (B)(6) 2015, PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS ADMITTED TO HAVE THE ABSCESS DRAINED. FOLLOWING SEVERAL ATTEMPTS OF CONTACT WITH PRESCRIBER, NO ADDITIONAL INFORMATION ON THE HOSPITALIZATION WAS PROVIDED. AT THE TIME OF THE REPORT, THE PATIENT HAD NOT RESTARTED OPTUNE. SPOUSE REPORTED THAT THE PRESCRIBER HAD ATTRIBUTED THE EVENT TO OPTUNE, BUT THIS WAS NOT CONFIRMED BY THE PRESCRIBER.

  Patient problems: Abscess

  MAUDE report 5160135 ↗
• InjuryOct 19, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015, NOVOCURE WAS INFORMED THAT ON APPROXIMATELY (B)(6) 2015, THE PATIENT HAD BEEN HOSPITALIZED DUE TO NEW ONSET SEIZURE. THE PATIENT WAS UNSURE OF WHAT HAPPENED PRIOR TO ADMISSION AND "WOKE UP" AFTER A FEW DAYS IN THE HOSPITAL. OPTUNE WAS TEMPORARILY DISCONTINUED UPON ADMISSION. THE PATIENT WAS STARTED ON UNSPECIFIED ANTI-SEIZURE MEDICATION. NO FURTHER DETAILS ON THE HOSPITALIZATION WERE AVAILABLE. PATIENT IMPROVED WITH NO FURTHER SEIZURE ACTIVITY. PATIENT WAS DISCHARGED APPROXIMATELY TWO WEEKS LATER AND RESUMED OPTUNE THERAPY. PRESCRIBING PHYSICIAN STATED THAT THE EVENT WAS CAUSED BY EDEMA FROM PSEUDO-PROGRESSION AND WAS UNRELATED TO OPTUNE THERAPY.

  Patient problems: Seizures

  MAUDE report 5159112 ↗
• InjuryOct 6, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT ANAPLASTIC OLIGOASTROCYTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2015. FOLLOWING A SCHEDULED MRI ON (B)(6) 2015, PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ELEVATED BLOOD PRESSURE. OPTUNE WAS DISCONTINUED UPON ADMISSION. FURTHER TESTING REVEALED THROMBOSES AND PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE TO "PREVENT CLOTS FROM TRAVELING TO THE LUNGS." PATIENT HAD NO HISTORY OF THROMBOEMBOLIC DISEASE. FOLLOWING THE PROCEDURE, PATIENT EXPERIENCED THREE SEIZURES (NO FURTHER INFORMATION PROVIDED), BUT OTHERWISE REMAINED STABLE. PATIENT DID NOT HAVE A HISTORY OF SEIZURE AND WAS NOT ON ANTI-SEIZURE MEDICATION. PATIENT WAS DISCHARGED ON (B)(6) 2015 WITH HOME HOSPICE CARE AND PLANNED TO RESTART OPTUNE THERAPY. PER PRESCRIBING PHYSICIAN, THE EVENTS WERE NOT RELATED TO OPTUNE THERAPY.

  Patient problems: Seizures; Thrombosis

  MAUDE report 5130286 ↗
• InjuryOct 5, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH RIGHT SIDED FACE, HAND, AND LEG WEAKNESS AND DIFFICULTY EXPRESSING WORDS. WITH SOME MOVEMENT OF THE RIGHT HAND. SHORTLY AFTER ARRIVAL, THE PATIENT EXPERIENCED A FOCAL SEIZURE AND HAD DIFFICULTY EXPRESSING WORDS AND WAS UNABLE TO MAINTAIN RESPIRATION. THE PATIENT WAS INTUBATED AND ADMITTED TO INTENSIVE CARE WITH VENTILATOR SUPPORT AND INTRAVENOUS FLUIDS. PATIENT HAD EXPERIENCED 1 PRIOR SEIZURE IN 2002 BUT HAD NO SEIZURES SINCE GBM DIAGNOSIS ((B)(6) 2014). PATIENT WAS ON TOPIRAMATE 100 MG TWICE DAILY FOR SEIZURE CONTROL AT TIME OF HOSPITALIZATION AND WAS SUBSEQUENTLY STARTED ON VALPROATE 500 MG TWICE DAILY WHILE IN-PATIENT. CT SCAN SHOWED QUESTIONABLE BRAINSTEM INFARCT AND PATIENT WAS STARTED ON LOW-DOSE ASPIRIN FOR STROKE PREVENTION. EEG WAS ABNORMAL DUE TO PRESENCE OF SLOW WAVES RANGING 4-6HZ, POSSIBLY REPRESENTING ENCEPHALOPATHY. MRI SHOWED CENTRAL AND CORTICAL ATROPHY, AND CHANGES OF CHRONIC PERIVENTRICULAR ISCHEMIA, AND AN AREA OF ABNORMAL DIFFUSION RESTRICTION INVOLVING THE LEFT POSTERIOR CORPUS CALLOSUM AND ADJACENT TO THE LEFT LATERAL HORN.

  Patient problems: Infarction, Cerebral; Respiratory Failure; Seizures, Focal Motor

  MAUDE report 5127478 ↗
• InjurySep 21, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6), 2015. ON (B)(6), 2015, PATIENT PRESENTED TO THE HOSPITAL WITH PAINFUL RESPIRATION, FEVER, AND TACHYCARDIA. CHEST CT SHOWED IRREGULAR AIRSPACE OPACITIES OF THE LOWER LUNGS, LIKELY DUE TO ATELECTASIS, NO PULMONARY ARTERIAL EMBOLISM, AND NO PERICARDIAL EFFUSION. CHEST X-RAY SHOWED UNDERINFLATED LUNGS, MINIMAL BIBASILAR ATELECTASIS, AND NO CONSOLIDATION. PATIENT WAS NOT ADMITTED TO THE HOSPITAL FOR THE EVENTS. ON (B)(6), 2015, PATIENT WAS ADMITTED FOR SHORTNESS OF BREATH AND HYPOXIA. PATIENT TEMPORARILY DISCONTINUED OPTUNE THERAPY UPON HOSPITALIZATION. CHEST CT SCAN REVEALED NEW ONSET BILATERAL PULMONARY EMBOLI (PE). PATIENT WAS TREATED WITH HEPARIN AND HEMATOCRIT LEVELS STABILIZED. DURING HOSPITALIZATION, THE PATIENT DEVELOPED LOWER EXTREMITY EDEMA. DOPPLER ULTRASOUND SHOWED NO DEEP VEIN THROMBOSIS (DVT). ON (B)(6), 2015, PATIENT WAS DISCHARGED WITH SELF-ADMINISTERED ENOXAPARIN AND PLANNED TO RESUME OPTUNE THERAPY. PATIENT DID NOT HAVE A HISTORY OF PE/DVT AND WAS NOT ANTI-COAGULATION THERAPY AT THE TIME OF THE EVENT. PER PRESCRIBING PHYSICIAN, THE CAUSE OF THE PE WAS THE PATIENT'S HYPERCOAGULABLE STATE SECONDARY TO GL

  Patient problems: Pulmonary Embolism

  MAUDE report 5090825 ↗