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

Model Number RNS-300M-K

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Edema (1820); Headache (1880); Visual Impairment (2138); Fluid Discharge (2686)

Event Date 09/04/2014

Event Type  Injury  

Event Description

(b)(6) 2014: patient implanted with rns neurostimulator (rns-300m-k) and (1) neuropace depth lead (dl-344-3.5-k) placed in left frontal-temporal region and (1) neuropace depth lead (dl 344-10-k) placed in the right hippocampus.(1) neuropace burr hole cap and cover were used to secure the dl-344-3.5-k in the right hippocampus.(b)(6) 2014: patient returned to clinic complaining of a severe headache along with drainage at the right burr hole cover site.Patient was taken to surgery where the (r) dl- 344-10-k was cut and partially explanted along with the burr hole cap and cover.The rns-300m-k neurostimulator and (l) frontal-temporal dl-344-3.5-k remain in place.Post-op the patient was started on antibiotics and is being followed by infectious disease.Cultures were sent to pathology.The burr hole cap and cover along with the partially removed (r) dl 344-10-k were discarded by the site.(b)(6) 2014: patient developed a left visual field deficit.Ct scans revealed an encapsulated abscess which was drained and the patient was started on decadron.(b)(6) 2014: patient discharged to home on iv antibiotics x 6 weeks per id.Left visual deficit has resolved.Serial ct scans reveal a reduction in edema.Patient will remain on iv antibiotics x 6 weeks and oral antibiotics x 2 years per id.Neurosurgeon and epileptologist will continue to closely follow patient.

Manufacturer Narrative

(b)(4).No product to be returned.Product was discarded by reporter.

• 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: 4116139
• MDR Text Key: 4940548
• Report Number: 3004426659-2014-00007
• 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: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• 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): Hospitalization
• Patient Age: 19 YR