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

Model Number RNS NEUROSTIMULATOR

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

Patient Problem Impaired Healing (2378)

Event Date 03/16/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 the subject was implanted with the rns neurostimulator, a depth lead (dl-330-10-k) and two strip leads (cl-325-10-k).On (b)(6) 2015 the subject was seen in clinic reporting a portion of the surgical wound not healing.The doctor determined a wound revision was required.On (b)(6) 2015 wound revision was performed.The doctor reported there was no sign of infection.On (b)(6) 2015 follow up - the doctor reported no evidence of infection and no removal of any rns system implantable components.The rns system remains implanted and is programmed for detection and therapy for epilepsy treatment.

Manufacturer Narrative

(b)(4).On 5/08/2015 neuropace, inc.Voided this complaint.There was no reported product malfunction and no indication the product contributed to the event.The risk of the noted condition had been previously assessed and mitigated, and the routine actions taken were consistent with standard patient care, providing effective treatment for the subject.The subject.On 7/1/2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with wound healing may be reportable.These past events show no indication that the product caused the wound not to heal and there is no indication of product failure.The rns system remains implanted and is programmed for detection and therapy for epilepsy treatment.Device remains 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: 4954024
• MDR Text Key: 6196270
• Report Number: 3004426659-2015-00007
• 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: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 07/30/2015
• 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): Required Intervention
• Patient Age: 42 YR