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 2018-02-20 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[100470853]
Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy. The patient had a history of seizures and was on anticonvulsants. Seizures were reported as adverse events in 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 (22% and 21% in optune/tmz and tmz arms respectively). None of these seizures were considered device or chemotherapy related by investigators. Seizures are a known complication of gbm and have been reported as the presentation symptom in 27% of cases. During the course of the disease, 51% of patients will experience seizures (clin neurol neurosurg. 2015; 139:166-171).
Patient Sequence No: 1, Text Type: N, H10
[100470854]
A (b)(6) patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2018, novocure was informed that the patient had been hospitalized on (b)(6) 2018, following a seizure. When contacted for additional information, the prescribing physician reported that the patient had previously experienced a new onset seizure in (b)(6) 2017 and had been treated with levetiracetam and valproic acid. The prescriber did not provide any additional details on the (b)(6) hospitalization. On (b)(6) 2018, the prescriber noted that the patient had reported to him that "she occasionally forgets how to turn off and on the device while plugging it to be charged and she use the wrong buttons which results in [a]... Malfunction". The prescriber stated that this may be responsible for increasing her seizures while already on anti-seizure medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00091 |
| MDR Report Key | 7283408 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-02-01 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2018-02-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-02-20 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 19 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-02-20 |