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 2017-12-05 for OPTUNE TFH 9100 manufactured by Novocure Ltd.
[93725514]
Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy. Seizures were reported as adverse events in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial ((b)(6) in optune/tmz and tmz arms respectively). None of these seizures were considered device or chemotherapy related by investigators. Additional risk factors for seizure in this patient include: concomitant temozolomide [convulsions are listed as among the most common adverse reactions. Source: temozolomide prescribing information] and concomitant dexamethasone [convulsion is listed as a known adverse reaction. Source: dexamethasone prescribing information]. Seizures are a known complication of the underlying disease (gbm).
Patient Sequence No: 1, Text Type: N, H10
[93725515]
A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On october 19, 2017, novocure was informed that the patient had been hospitalized on (b)(6) 2017, due to new onset seizure. Per hospital summary, patient presented to the emergency room with walking difficulties and numbness in the right leg and arm. In the er, the patient developed slurred speech and confusion. Optune therapy was temporarily discontinued upon hospital admission. The patient was started on intravenous anti-seizure medication (levetiracetam 500 mg bid). Eeg demonstrated epileptic activity in the left parietal region. Ct scan was negative for tumor progression. On (b)(6) 2017, the patient was discharged home with outpatient care. The patient resumed optune therapy after a 4 day treatment break with no further seizure activity reported. The prescribing physician could not rule out that optune therapy contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2017-00089 |
| MDR Report Key | 7082828 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2017-01-18 |
| Date Added to Maude | 2017-12-05 |
| 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 | US |
| 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 | 2017-12-05 |
| Model Number | TFH 9100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 10 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 US 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-12-05 |