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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace for analysis.Review of the rns neurostimulator ecogs and lead impedances confirmed that the ecog data were suggestive of a potential lead break.
Event or Problem Description
During a routine clinic appointment, the rns neurostimulator was interrogated, however impedance measurements would not read for the left depth lead, suggestive of a lead break.Further review of recorded ecogs noted that a change in the signals from the lead was noted around (b)(6) 2018.The patient did not recall a specific trauma or fall on or around that date but noted that he has a tendency to fall out of bed during generalized tonic-clonic seizures and hit his head on a nearby nightstand.No programming changes were made on the affected lead during the office appointment.During a routine rns battery replacement procedure performed on (b)(6) 2019, the affected lead was explanted and a new depth lead was implanted and connected.No complications were reported during the procedure.
Additional Manufacturer Narrative
(b)(4) the explanted lead was returned to neuropace for analysis.The investigation included visual inspection and electrical testing.Confirmed lead damage.We were unable to determine the cause of the damage to the lead coil.
Event or Problem Description
The product was received and investigated by neuropace.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 8850710
• Report Number: 3004426659-2019-00033
• Device Sequence Number: 286414
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417200921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 24507-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR