MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number 71005

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/05/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023.In (b)(6) 2024 the patient reported inadequate pain relief due to intermittent communication between the implantable pulse generator (ipg) and the external therapy discs.Xray imaging confirmed that the ipg had migrated within the pocket, causing the symptoms.On (b)(6) 2024 a surgical revision was performed in which a new pocket was created and a new ipg was placed.

Manufacturer Narrative

There are no indications of any system or component failure.The surgical plan had been to reposition the existing ipg, however the component was damaged during the procedure, necessitating the placement of a new device.Migration of implanted components is a known inherent risk of implantable neruomodulation systems.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18853405
• MDR Text Key: 337069649
• Report Number: 3015425075-2024-00073
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123081517260815
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• 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: 83 YR
• Patient Sex: Female