MAUDE Adverse Event Report: NEUROPACE RNS NEUROSTIMULATOR KIT; IMPLANTED BRAIN STIMULATOR FOR EPILEPSY

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 09/19/2020

Event Type  Injury  

Event Description

Recently, patient admitted to hospital with stroke symptoms.Subsequent, imaging revealed brain hemorrhage at the site of one of the electrodes originally placed in [date redacted] at another facility.

Event Description

Recently, patient admitted to hospital with stroke symptoms.Subsequent, imaging revealed brain hemorrhage at the site of one of the electrodes originally placed in [date redacted] at another facility.

• Brand Name: RNS NEUROSTIMULATOR KIT
• Type of Device: IMPLANTED BRAIN STIMULATOR FOR EPILEPSY
• Manufacturer (Section D): NEUROPACE; 455 n. bernardo avenue; mountain view CA 94043
• MDR Report Key: 10599366
• MDR Text Key: 208947727
• Report Number: 10599366
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2020
• Device Age: 12 YR
• Date Report to Manufacturer: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12045 DA
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White