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

Model Number 1007609

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

Patient Problems Hematoma (1884); Weakness (2145)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Two strip leads were explanted from the patient (sn (b)(4)).Neuropace received the distal end of two strip leads from the site.There are no distinguishable marks on the returned leads so we are unable to determine the serial number of each lead.Medical affairs: review of the describe event by the site along with review of findings from internal investigation of the two returned explanted leads and with an understanding of head injuries that can lead to subdural bleeds it is impossible to make a definite conclusion on the contributing factor the implanted cortical strip lead may have had in relation to the subdural bleed.

Event Description

(b)(6) 2016 - patient was implanted with the rns system including the neurostimulator, connected leads include a depth lead (dl) (left temporal heterotopia) and cortical strip lead cl ((b)(4), left parietal-superior).Not connected cl (sn (b)(4), left parietal inferior).(b)(6) 2016 - the patient presented to clinic on (b)(6) 2016 because he developed sudden onset right hand weakness on (b)(6) which progressively got worse over the next three days.Weakness presented as follows: right upper extremity weakness.He was unable to neither hold a toothbrush nor feel his hand.He came in and had numbness in his right 3rd, 4th, and 5th digit.Right upper extremity for his motor exam was all 4 out of 5 (deltoid, tricep, bicep, hand grip).He had reported that he had bumped his head on the tractor ((b)(6)) and had a mild headache thereafter with some scalp tenderness but no issues arose until (b)(6).He was taken to the or for exploratory surgery which revealed a small subdural hematoma found on top of one of the subdural strips.It is not clear if it was the connected or non-connected strip.The cortical strip leads were explanted, the left hippocampal depth electrode remains implanted, connected and programmed for detection and therapy.Total procedure was deemed a left craniotomy for subdural evacuation and wound exploration.The site was unable to determine the initial cause for the hematoma because of the sequence of events.The patient hit his head on (b)(6) 2016, they are unable to determine whether or not the hitting of the head or the electrode was the cause or provided exacerbation of the hematoma.(b)(6) 2016 - the patient was released from the hospital.The patient continues to be programmed for detection and treatment with the remaining implanted rns system.

• 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: 5967709
• MDR Text Key: 55315569
• Report Number: 3004426659-2016-00022
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917180729
• 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: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• 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; Required Intervention
• Patient Age: 39 YR