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

Model Number DL-344-3.5-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted lead was not returned to neuropace for analysis, however review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Unable to determine root cause.

Event Description

Neuropace became aware of a possible lead break based on review of the patient's ecog data in (b)(6) 2019 and the treating center was notified.The rns system remained implanted with stimulation and detection enabled.The center performed confirmatory testing in clinic; however the testing was limited due to the clear signal change and abnormal impedance measurements.The right depth lead was subsequently explanted and a new lead implanted on (b)(6) 2019 during a routine neurostimulator 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: 8898197
• MDR Text Key: 154540307
• Report Number: 3004426659-2019-00037
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117150911
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007606
• Device Lot Number: 19102-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• 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: 38 YR