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

Model Number CL-335-10-K

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient did not have the rns neurostimulator implanted therefore the leads were inactive.Explanted leads included: cl-335-10-k (sns (b)(4)), cl-325-10-k (sns (b)(4)).

Event Description

The patient was implanted on (b)(6) 2017 with four cortical strip leads which were secured to the dura with sutures; a rns neurostimulator was never implanted.On (b)(6) 2018 the leads were explanted to treat an infection.

• 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: 7853759
• MDR Text Key: 119488801
• Report Number: 3004426659-2018-00030
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217171105
• 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: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1007610
• Device Lot Number: 19368-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• 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): Hospitalization; Other
• Patient Age: 9 YR