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

Model Number 1007603

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

Patient Problem Unspecified Infection (1930)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Rns system explant included the following components: product description serial number part number cl-325-10-k (b)(4) 1007609 cl-325-10-k (b)(4) 1007609 cl-325-10-k (b)(4) 1007609 cl-315-10-k (b)(4) 1007608 rns-300m-k (b)(4) 1007603 product not returned.

Event Description

Explanted rns system as a result of infection.Explant date is estimated.Unable to obtain details of the reported issue.Review of patient ecog shows no indication of product malfunction or failure, prior to explant the device was programmed for detection.

Manufacturer Narrative

(b)(4).Infection occurred less than 30 days after implant.Patient presented with wound drainage.Infection classification: deep incisional infection - subgaleal sub bone flap.Treatment included explant of the rns system and iv cefepime for 6 weeks pre-implant procedures included preoperative antiseptic shower and electric shaver hair removal in the or.Antibiotics were administered 30-60 min prior to incision.Implant procedure lasted > 3 hours.No additional antibiotics were administered during surgery.Patient had a 12 day phase ii cranial monitoring prior to implant.Product not returned.

Event Description

Additional details received regarding the 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: 5633090
• MDR Text Key: 44448693
• Report Number: 3004426659-2016-00013
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160616
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• 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; Required Intervention
• Patient Age: 27 YR