MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-14 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[100049461]
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 on the (b)(6). 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). Seizures are a known complication of the underlying disease (gbm).
Patient Sequence No: 1, Text Type: N, H10
[100049462]
A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2017. On january 25, 2018, the spouse reported to novocure that the patient had been hospitalized due to a seizure. On (b)(6) 2018, the patient experienced generalized and right sided weakness, headache, confusion, and two episodes of tonic-clonic seizure. Generalized weakness and confusion continued after each seizure with post ictal amnesia. The following day the patient was transported and hospitalized after presenting with ongoing generalized weakness, fatigue, variable hypertension and fever. Patient temporally discontinued optune therapy during the hospital stay. Brain ct scan demonstrated no acute findings. Blood lab values showed low levels of anti-seizure medication (levetiracetam). Due to suspected encephalitis, cerebral spinal fluid culture and virus serology was ordered and came back negative. Meningitis test was negative. Ophthalmology was consulted and no papilledema was seen. Patient was started on an anti-viral medication (acyclovir), but this was discontinued after herpes test was negative. Patient was treated for seizure by increasing levetiracetam from 500 mg bid to 1000 mg tid. No additional seizure activity was reported. The patient was discharged on an unknown date. Per the prescribing physician, the patient did not have a history of seizures and the cause of the event was underlying gbm, hypertensive encephalopathy, and optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00090 |
| MDR Report Key | 7270045 |
| Report Source | CONSUMER |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2016-09-16 |
| Date Added to Maude | 2018-02-14 |
| 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, 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 | 2018-02-14 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 16 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 | 2018-02-14 |