MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	72011
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System has been in use and providing good pain relief to the patient with no clinical issues.Cause of the impedance issue is unknown as the device was not made available for inspection by the firm.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022.In april 2024 the firm received a request to perform impedance check for mri testing for an unrelated condition.Testing performed on 07may2024 returned high impedance readings on one contact of one implanted lead.On (b)(6) 2024 a surgical revision was performed to remove the lead with impedance readings and place a new lead.All other components remained implanted and in use.The explanted lead was discarded by the medical facility and is not available for examination by the firm.Patient reports continuing to receive good therapy after the revision and was able to procede with the requested mri testing.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• 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: 19640136
• Report Number: 3015425075-2024-00247
• Device Sequence Number: 15651847
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: 0100812537035628112105171724051710NW908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/28/2024

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: 05/17/2024
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: NW908
• 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: 05/30/2024
• Initial Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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