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

Model Number DL-344-10-K

Device Problems Signal Artifact/Noise (1036); Break (1069); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a routine review of ecog data neuropace representatives identified that the signal on the right lead was demonstrating insufficient charge and the signal appeared to have gone flat.A lead break was suspected.The patient confirmed that on the day of the noted signal change that they had a seizure and fell into the door hitting their head.The ecog for the seizure was recorded by the neurostimulator and clearly displays the signal for the lead going flat.Detection and stimulation were disabled on the right lead as many of the patient's seizures are left sided onset, so minimal impact to patient treatment was anticipated.A lead revision was subsequently performed on (b)(6) 2018 during a routine scheduled battery replacement.

• 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: 7557664
• MDR Text Key: 109684694
• Report Number: 3004426659-2018-00017
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007440
• Device Lot Number: 18860-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• 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: 47 YR