MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number 72006

Device Problem Malposition of Device (2616)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/16/2023

Event Type  Injury  

Event Description

Patient was implanted with nalu peripheral nerve stimulator on (b)(6) 2023 to target the cluneal nerve.During the implant procedure the physician inadvertently advanced the lead on the right side past the target point.Attempts were made to pull the lead back into the desired position but was unsuccessful.Procedure was closed leaving the lead in place.During activation on (b)(6) 2023 it was confirmed that the placement of the lead on the right side was not able to be programmed or otherwise manipulated to provide pain relief to the targeted area.On (b)(6) 2023, the patient underwent a surgical revision procedure to remove the original 4 contact tined leads as well as the implantable pulse generator (ipg).Patient was then implanted with replacement leads and ipg in the desired location to target the pain area.Case went smoothly and there were no complications reported.Post-op patient was doing well and recovering.

Manufacturer Narrative

Nalu rep was present during the initial implant procedure and confirmed malplacement of the implanted lead.Attempts were made during the implant to reposition but were unsuccessful.Additional attempts were made to use programming to mitigate the placement of the leads and were also unsuccessful.Fluoroscopy was used during the revision procedure to assure proper placement.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17088078
• MDR Text Key: 316854365
• Report Number: 3015425075-2023-00082
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112202161725021610QJ118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72006
• Device Catalogue Number: 72006
• Device Lot Number: QJ118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other