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

Model Number RNS NEUROSTIMULATOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/12/2015

Event Type  Injury  

Event Description

(b)(6) 2014 patient implanted with rns system including a neurostimulator, a depth lead (dl-330-10) placed in the left mesial temporal region, a cortical strip lead (cl-325-10) placed mid temporal region and two additional cortical leads (cl-325-10) placed in the temporal region that are not currently connected.(b)(6) 2015 programming was modified.(b)(6) 2015 dr.(b)(6) emailed reporting that patient contacted his office because he was "feeling brief shocks on left side of head where device is." (b)(6), (b)(6) and (b)(6) 2015 patient reported that during physical therapy he was receiving external stimulation to help treat his arthritis/stiffness/pain in his legs, back and neck.These dates correspond to artifacts observed in the ecogs.(b)(6) 2015 programming was modified - he was seen by dr.(b)(6).During stim testing, dr.(b)(6) was able to reproduce the shocking sensation when testing burst 2 that was programmed as lead to lead with the hippocampus depth lead programmed as '+' and the mid temporal basal strip lead programmed as '-'.Dr.(b)(6) reprogrammed the patient with a bipolar configuration on the mid temporal basal strip and decreased the current on this lead.Patient did not report any shocking sensation when stim testing was done at this new setting.Patient was also told that he should not have external stim done again.(b)(6) 2015 dr.(b)(6) nurse emailed saying patient is "still having shocks." (b)(6) 2015 event reported to neuropace product monitoring and complaint file initiated.Note that physicians thought prior to (b)(6) 2015 that the stimulation was due to the physical therapy stimulation which has been determined to be tens treatment.Patient has also been doing very well from an epilepsy standpoint.No seizures reported at last appointment.

Manufacturer Narrative

(b)(4).Device remians implanted.

• 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: 4929809
• MDR Text Key: 21795019
• Report Number: 3004426659-2015-00021
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• 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: 62 YR