MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-04-30 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[106929837]
Novocure medical opinion is that a contribution of device use to the event cannot be ruled out. Other contributing factors in this patient include: concomitant temozolomide (headache is listed as a common adverse event. Source: temozolomide prescribing information) and underlying disease (tumor progression reported in month prior to event). 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 a common symptom of disease in gbm.
Patient Sequence No: 1, Text Type: N, H10
[106929838]
A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2018, the patient reported that he had been hospitalized for one night due to headache experienced while using optune therapy. No further information was provided. The prescribing physician was contacted for additional information with no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00100 |
| MDR Report Key | 7473924 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-04-30 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-04-30 |
| 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 | US |
| Manufacturer Postal | 31905 |
| Manufacturer Phone | 9724850120 |
| 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 | 2018-04-30 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 9 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, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-30 |