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

Model Number DL-344-10-K

Device Problems Break (1069); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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.

Event Description

On (b)(6) 2018, the treating center contacted neuropace field support personnel after noting artifact on the ecog signal from the patient's right depth lead.After review by neuropace, inc., it was determined the signal artifact noted was consistent with those seen with a potential lead break.The lead break was attributed by the treating center , as a lead routing issue, as the lead had ended up folding over on itself.The lead was explanted on (b)(6) 2018 and a new lead was placed on (b)(6) 2018.The lead was discarded at the treating center per the neurosurgeon's instructions; and therefore was not returned to neuropace for analysis.

• 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: 7807981
• MDR Text Key: 117959644
• Report Number: 3004426659-2018-00028
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417200626
• 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: Physician
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 24132-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• 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: 33 YR