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

Model Number DL-344-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  Injury  

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 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.

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 Description

The product was received and investigated by neuropace.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 8850710
• MDR Text Key: 152978006
• Report Number: 3004426659-2019-00033
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417200921
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR