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

Model Number DL-344-10-K

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The leads were returned to neuropace and investigated.There was evidence that the leads were damaged as a result of the explant procedure.There was no damage associated with the reported infection.The following leads were explanted; sn (b)(4), udi (b)(4).Sn (b)(4), udi (b)(4).

Event Description

Neuropace was notified that the patient developed an infection at the incision site and subsequently had both depth leads explanted on (b)(6) 2019.The surgical site was washed-out with an antibiotic solution after the leads were removed.Cultures from the procedure are pending.

Manufacturer Narrative

(b)(4).

Event Description

Culture results provided by 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
• 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: 8551031
• MDR Text Key: 143231734
• Report Number: 3004426659-2019-00013
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817200828
• 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,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 25991-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 16 YR