MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number DL-330-10-K

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

Patient Problem Edema (1820)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient reported unilateral left arm weakness after undergoing rns neurostimulator and leads placement on (b)(6) 2019.Patient was admitted for 2 weeks of inpatient monitoring and treatment, including ongoing neurological exams and administration of steroids.Ct scans were performed and indicated significant edema around the leads but was negative for hemorrhage.Lab testing was negative for infection.The treating center reported this as upper extremity weakness.No additional information was provided by the treating center.

Manufacturer Narrative

(b)(4).It was reported to neuropace that the patient's upper extremity weakness resolved after administration of decadron, and steroid treatment was tapered off.After the initial scan diagnosing the event, no further ct scans were performed.No additional information was provided by the treating center.

Event Description

Additional information was provided by the treating center.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 9050426
• MDR Text Key: 161204814
• Report Number: 3004426659-2019-00045
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517211015
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 26785-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR