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

Model Number 1007427

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

Patient Problem Head Injury (1879)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not received.

Event Description

Sn (b)(4) implanted on (b)(6) 2014, explanted on (b)(6) 2015.Patient is implanted with the rns neurostimulator, three cortical trip leads and one depth lead.For (b)(6) 2015 patient was struck by a basketball on (b)(6) 2015 and felt something inside his skull had moved out of place.His mom uploaded data to the neuropace pdms.On (b)(6) 2015 - patient was brought into or.It appears that the cranioplasty moved when the patient was hit in the head by the basketball as a result, the ferrule tab broke off of the ferrule.After the incision was made and skin flap pulled back they observed a broken screw on cranioplasty construct and a broken ferrule tab that was on the cranioplasty.The surgeon re-secured the cranioplasty with several screws and mesh then replaced the ferrule and neurostimulator.There was artifact noted on stored ecogs on (b)(6).The physician was able to reproduce artifact by palpating on the patient's scalp on (b)(6).After incision made, leads were carefully examined and impedances were measured; surgeon made decision to not replace leads.Patient is implanted with the rns neurostimulator, three cortical trip leads and one depth lead.The rns system is currently implanted and programmed for detection and treatment.

Manufacturer Narrative

(b)(4).Follow up information - investigation results: the rns neurostimulator and ferrule were returned to the manufacturer.After decontamination neuropace confirmed the neurostimulator had a dent and the ferrule was missing a tab as previously noted in photos provided by the field clinical engineer.It is believed that this damage was caused by the impact of the basket ball when it struck the patient.The neurostimulator functionality was not affected by the damage.

Event Description

Follow-up1 report - update investigation results.

• 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: 5233131
• MDR Text Key: 31506102
• Report Number: 3004426659-2015-00033
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• 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: 20 YR