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	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2020.In (b)(6) 2023 the patient reported connectivity issues between the implantable pulse generator (ipg) and the external therapy discs, ultimately causing disruption in therapy and inadequate pain relief.It was determined that the ipg had migrated due to loss of tissue around the pocket area after the patient sustained a significant loss of weight.On (b)(6) 2023 a revision procedure took place in which the ipg and implanted leads were replaced and the new ipg was placed in a new location with sufficient tissue present.
Additional Manufacturer Narrative
There are no allegations of device or system failure.The initial plan for this patient was to move the existing ipg to a different location, however during the procedure the device was damaged due to handling and required replacement.The medical facility declined to release the implanted components due to internal policies.Migration is a known inherent risk of implantable neuromodulation systems and in this case appears to be directly related to the patient's changes to physical anatomy that took place three years after the initial implant procedure.

• 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: 17892710
• Report Number: 3015425075-2023-00239
• Device Sequence Number: 15370444
• Product Code: GZB
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941121081017240810
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 10/08/2023

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: 08/10/2024
• 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: 09/08/2023
• Initial Report FDA Received Date: 10/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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