MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-12 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[99799556]
Novocure medical opinion is that a contribution of device use to the event cannot be ruled out. Migraine was not reported as an adverse event in the (b)(6) trial in recurrent gbm. There has been 1 other report of migraine in the commercial program to date. Headaches were reported on the pivotal (b)(6) trial as an adverse event in both arms of the trial (16% optune therapy and 10% chemotherapy arm). They were attributable to the device in 3% of cases and to chemotherapy in 2% of cases. Headache is a common symptom of disease in gbm.
Patient Sequence No: 1, Text Type: N, H10
[99799557]
Patient is a (b)(6) male with recurrent glioblastoma who began optune therapy on (b)(6) 2017. On (b)(6) 2017, spouse reported patient was brought to the hospital the night before and had discontinued device use. On november 14, 2017, spouse provided additional information regarding the cause of the hospitalization. According to the spouse, the patient had been brought to the hospital for a suspected seizure, but was subsequently diagnosed with a complex migraine and sequelae of a previous stroke (no further information provided). Physician was contacted for additional information and on january 11, 2017, he reported that prior to the hospitalization, the patient had experienced visual changes followed by progressive worsening headache, worsening right sided weakness, worsening expressive aphasia, and worsening concentration over the course of several hours. Mri was negative for disease progression. Patient was treated with headache management including iv pain medications. Out of concern for seizure, levetiracetam dose was increased. Symptoms improved with headache management therefore it was felt this was more likely a migrainous phenomenon and patient was started on migraine prophylaxis. Levetiracetam was reduced to the previous dose with further improvement in neurologic symptoms. On an unknown date, patient was discharged and subsequently entered hospice due to disease progression. Optune therapy was not restarted. Physician attributed the symptoms to underlying disease progression; however, he was unable to say if optune had any role in triggering the migraine component to the patient's presentation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00093 |
| MDR Report Key | 7263351 |
| Report Source | CONSUMER |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-15 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-02-12 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, IL 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE LTD |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, IL 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31905 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2018-02-12 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE LTD |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA, IL 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-02-12 |