FDA Adverse Event Injury Summary report: N

OPTUNE GIO

MDR report key: 19630982 · Received June 28, 2024

Report

Report Number: 3010457505-2024-00292
Event Type: Injury
Date Received: June 28, 2024
Date of Event: May 28, 2024
Report Date: June 28, 2024
Manufacturer: NOVOCURE GMBH
Product Code: NZK
UDI-DI: 07290107982214
PMA / PMN Number: P100034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF DEVICE USE TO THE HEADACHE CANNOT BE RULED OUT. NAUSEA IS A COMMON SECONDARY SYMPTOM OF HEADACHE. HEADACHE IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 16% AND 28% EF-14 OPTUNE ARM).

Description of Event or Problem · 0

A 49-YEAR-OLD FEMALE WITH RECURRENT GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON (B)(6) 2024, THAT THE PATIENT EXPERIENCED HEADACHES AND NAUSEA SINCE STARTING OPTUNE GIO THERAPY. ON (B)(6) 2024, THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY SINCE (B)(6) 2024. NOVOCURE RECEIVED ADDITIONAL INFORMATION ON (B)(6) 2024, THAT THE FOUR DAYS THE PATIENT WAS ON OPTUNE GIO THERAPY, SHE WAS MISERABLE DUE TO HEADACHES THAT SUBSEQUENTLY LED TO BEING HOSPITALIZED. PER AN AVAILABLE MEDICAL RECORD, IT WAS DISCOVERED THE PATIENT HAD A HISTORY OF CHRONIC MIGRAINE HEADACHES WITHOUT AURA. THE PATIENT ENDED OPTUNE GIO THERAPY ON (B)(6) 2024. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2215273	OPTUNE GIO	OPTUNE GIO	NZK	NOVOCURE GMBH	TFH9100		07290107982214

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR	Female	Hospitalization\| O	ALBUTEROL\| DEXAMETHASONE\| FUROSEMIDE\| GABAPENTIN\| LORAZEPAM\| MECLIZINE\| ONDANSETRON\| PANTOPRAZOLE\| SPIRONOLACTONE\| TORSEMIDE