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

Model Number RNS-320-K

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rns system remains implanted and programmed for use.The surgeon was unable to locate nor remove the dislodged screw.

Event Description

On (b)(6) 2020, the patient experienced a seizure resulting in a fall involving head trauma after not taking his prescribed anti-seizure medications.It was not communicated to neuropace how many doses of anti-seizure medication the patient skipped.The patient has a baseline history of falls with seizures and associated trauma.Post-seizure, the patient reported feeling something "sharp" in the area of the neurostimulator.The patient was seen by the treating clinician on (b)(6) 2020 and x-rays identified a screw which was no longer attached to the ferrule.On (b)(6) 2021, the patient underwent a procedure to replace the dislodged screw.During the surgical procedure, the neurosurgeon was unable to locate the dislodged screw for removal.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 11877308
• MDR Text Key: 252418000
• Report Number: 3004426659-2021-00034
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30015-1-1-1
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR