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

Model Number	71004
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back pain.On 01apr2024 the patient was seen by a representative of nalu for system activation.The system was not able to establish communication between the implantable pulse generator (ipg) and the external therapy discs.Xray imaging was performed and showed the ipg had migrated, causing the lack of communication.Surgical revision was performed on (b)(6) 2024.During the procedure the physician damaged the existing ipg and a new one was implanted in a more optimal position.Intra-op testing showed the system was functioning as expected.
Additional Manufacturer Narrative
There is no indication that the nalu system failed or malfunctioned, however the device was damaged during the procedure and was not returned to the firm for evaluation.Xray imaging confirmed device migration, which is thought to be the cause of the communication error.Migration of implanted components is a known inherent risk of implantable neuromodulation devices.

• 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: 19372438
• Report Number: 3015425075-2024-00189
• Device Sequence Number: 7538082
• Product Code: GZB
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941121060817240608
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/22/2024

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: 06/08/2024
• Device Model Number: 71004
• Device Catalogue Number: 71004
• 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: 04/23/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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