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

Model Number	71005
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2022.Patient subsequently noted that there were issues with communication between the implantable pulse generator (ipg) and the external therapy discs which was determined to be caused by the depth of the ipg.A surgical revision was performed on (b)(6) 2023 to move the ipg to a more superficial location (see mdr 3015425075-2023-00014).Investigation was conducted at the time of the revision and was unable to fully determine if the device had migrated or was incorrectly positioned at the time of implant.After the revision, the patient again reported ongoing communication issues between the ipg and the therapy discs, causing sporadic pain relief therapy.On (b)(6) 2023 a second revision was performed to move the ipg to a position that is more conducive to connectivity between the devices.
Additional Manufacturer Narrative
During the patient's first revision procedure it was noted that the patient's anatomy may have contributed to connectivity issues.When the patient was in a supine position the ipg was in a skin fold.It is likely the skin fold was not present when the patient was in a prone position for the implant procedure.Moving the ipg to a more superficial position during the initial revision may have not been sufficient to fully resolve the anatomical involvement in the device communication.The second revision sought to locate the ipg in a flat area on the patient's body in order to avoid skin folds or skin and flesh movement that could impede with device connection.There are no allegations of device or component failure and no components have been replaced at either revision procedure.The communication issues noted appear to be solely related to positioning of the implanted components.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: 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: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17580015
• Report Number: 3015425075-2023-00195
• Device Sequence Number: 8368025
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001122031117250311
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Device Lot Number: A03726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown