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

Model Number 1007609

Device Problem High impedance (1291)

Patient Problem Headache (1880)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

Patient was implanted with a neuropace neurostimulator and one neuropace depth lead and one neuropace cortical strip lead on (b)(6) 2015.The patient began complaining of headaches in (b)(6) 2015.The center reviewed the patients stored ecogs on the neuropace patient data management system and noted several stored ecogs with high amplitude artifact.The patient was seen by the center and the physician performed palpation of the scalp in the vicinity of the lead location and was able to duplicate similar high amplitude artifact on the real time ecog.Review of historical lead impedances showed an increase in lead impedances on the cortical strip lead.Physician also performed test stimulation and at higher currents the patient complains of pinching sensation at lead site.Patient had a ct scan performed and no evidence of a bleed or other abnormality.Evidence suggests a lead breakage but were unable to confirm via a ct scan.The artifact appears to occur infrequently on stored ecogs.Unable to determine the cause of the headache at this time.

• 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: 5285233
• MDR Text Key: 33134546
• Report Number: 3004426659-2015-00035
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917180413
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007609
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• 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): Other
• Patient Age: 27 YR