MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB GAMMA KNIFE RADIOSURGERY; SYSTEM, RADIATION THERAPY, RADIONUCLIDE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 06/27/2019

Event Type  Injury  

Event Description

Patient found to have seizure like activity such as foaming at the mouth and shaking by family on 06/27/2019 and was brought to local emergency department.Eeg completed during hospitalization and was negative for seizure activity.No further seizure like activity since that event.Nct # (b)(4).Ctcae v4 grade z seizure unlikely related.Dates of use: (b)(6) 2019.Diagnosis of reason for use: brain metastasis.

• Brand Name: GAMMA KNIFE RADIOSURGERY
• Type of Device: SYSTEM, RADIATION THERAPY, RADIONUCLIDE
• Manufacturer (Section D): ELEKTA INSTRUMENT AB
• MDR Report Key: 8842898
• MDR Text Key: 152982054
• Report Number: MW5088510
• Device Sequence Number: 1
• Product Code: IWB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 101