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 Wound Dehiscence (1154)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

Patient underwent a neurostimulator replacement procedure as the neurostimulator had reached its elective replacement indicator level.The procedure occurred on (b)(6) 2016.There were no changes to the implanted depth leads.Upon neurosurgical clinic follow-up the neurosurgeon noted that the patient had elected to remove several of her incisional stitches causing an opening in the incisional area.The neurosurgeon noted that the area appeared non-infected however, he opted to take the patient back to the operating suite for a wound irrigation with antibiotic solution and closure of the incision.

• 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: 5580027
• MDR Text Key: 42744996
• Report Number: 3004426659-2016-00011
• 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
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• 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
• Date Manufacturer Received: 03/24/2016
• 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
• Patient Age: 34 YR