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

Model Number DL-330-10-K

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems Head Injury (1879); Injury (2348)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a routine rns neurostimulator replacement, the surgeon noted that it appeared as if the outer insulation layer was coming off a small region of the lead body, a few centimeters away from the neurostimulator on the lead connected to port 1.The surgeon stated the insulation had penetrated into the patient's scalp and caused a small wound.The lead demonstrated normal signals and impedance measurements upon connection and testing with the new neurostimulator.For this reason the lead was not explanted.Prior to closing the scalp incision, the surgical site was irrigated with pulsed lavage, and a patch of dura regeneration matrix was placed between the scalp and the region of the lead body where the insulation layer was coming off.No additional information nor were any pictures of the area of the lead in question were provided by the 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: 8201779
• MDR Text Key: 131585696
• Report Number: 3004426659-2018-00050
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517180310
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 20016-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• 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): Required Intervention
• Patient Age: 22 YR