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

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

Patient Problems Headache (1880); Hydrocephalus (3272); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2022

Event Type  Injury  

Event Description

Required shunt placement; following replacement of rns (b)(6) 2022, pseudomeningocele near area of implant developed.Over the next several weeks, headaches of increasing severity developed, along with tense 'fluid bubble' under the scalp.After 2 wks of very severe headaches, ct indicated hydrocephalus.Brought to emergency room, and surgical placement of shunt.Diagnosed with obstructive hydrocephaly, shunt placed to allow drainage of csf.Rns remained in place.Surgical shunt placement (b)(6) 2022.F/u ct indicated reduction in ventricle size.On (b)(6) 2022 (replacing device implanted in (b)(6) 2017).

• Brand Name: RNS
• Type of Device: IMPLANTED BRAIN STIMULATOR FOR EPILEPSY
• Manufacturer (Section D): NEUROPACE
• MDR Report Key: 14117701
• MDR Text Key: 289454948
• Report Number: MW5109010
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ONFI; VIMPAT; ZONEGRAN
• Patient Outcome(s): Hospitalization
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic
• Patient Race: White