MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-26 for OPTUNE TFH91000 N/A manufactured by Novocure, Ltd..
[115103327]
Novocure medical opinion is that a contribution of device use to the headache cannot be ruled out. Headaches were reported on the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (28% and 20% in optune/tmz and tmz arms respectively). Headache is also a common symptom of disease in gbm.
Patient Sequence No: 1, Text Type: N, H10
[115103328]
A (b)(6) male with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2018. On (b)(6) 2018, patient was hospitalized with severe head pain while using optune. Optune was discontinued upon admission. At the time of the report, prescribing physician assessed the headache as related to optune therapy. Ct scan showed no gross evidence of acute pathology or significant change since previous scan. Mri showed mild edema with no progression. Patient was continued on dexamethasone and started on fentanyl for the headache. Patient was discharged on (b)(6) 2018. On (b)(6) 2018, patient was readmitted to the hospital with continued headache as well as delirium, dysphagia, hiccups and immobility. Patient was found to be over sedated with fentanyl. Dexamethasone and fentanyl were discontinued and patient was started on methylprednisolone and hydromorphone. Headache was assessed as secondary to intracranial disease per hospital discharge summary. Patient was discharged (b)(6) 2018 in improved condition. Per the prescribing physician, the cause of the headache was uncertain but the patient was cleared to resume optune therapy. On (b)(6) 2018, the patient's spouse reported that the patient had tried to resume optune therapy but after about 3 hours, his headache started again and he went back to the hospital. There was no report of hospital admission or treatment for the event. No further information was provided. On july 19, 2018, novocure was informed that the patient had permanently discontinued optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00105 |
| MDR Report Key | 7722302 |
| Report Source | CONSUMER |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2016-07-22 |
| Date Added to Maude | 2018-07-26 |
| 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 |
| 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, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 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 | 2018-07-26 |
| Model Number | TFH91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| 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, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-07-26 |