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

Model Number	71005
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had undergone previous surgical revisions to reposition or relocate the existing implanted components (see mdr 3015425075-2023-00014 and 3015425075-2023-00195).It is likely that multiple instances of handling the components led to damage that was not clear on the images.Migration of the ipg likely exacerbated the damage and caused the impedance readings noted as well as contributing to poor communication between the ipg and the external therapy discs.
Event or Problem Description
On (b)(6) 2024 the patient met with a nalu representative for impedance check due to inadequate pain relief from the nalu system.Impedance check returned readings indicating an open circuit or possible short in the system.Imaging found the implantable pulse generator (ipg) had migrated within the pocket but showed no other obvious damage to the system components.Surgical revision was performed on (b)(6) 2024 to replace the ipg.Existing leads remained implanted and in use.Existing leads were tested intra-op with a known good device to confirm no issues with the leads and verify only the ipg had been damaged.Additional intra-op testing confirmed the replacement ipg returned good impedance readings and was functioning as expected prior to closing the case.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19150215
• Report Number: 3015425075-2024-00138
• Device Sequence Number: 13104674
• 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
• Device Explanted Year: 2024
• 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): 04/20/2024

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
• 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: 03/22/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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