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

Model Number	74001
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Nalu was made aware of a planned revision on (b)(6) 2022.On (b)(6) 2021 the patient reported that when sitting down, the nalu external transmitter modules (etms) will disconnect and start beeping.It was noted that the patient's skin is very loose and the external disc moves easily on the skin when the patient changes positions.The nalu representative attempted multiple troubleshooting strategies.Ultimately the physician and patient decided to revise the implant to a different style that does not require external components.Nalu became aware of this decision on (b)(6) 2022.No other information is available as to status or outcome of the procedure.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; carlsbad 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: 14982692
• Report Number: 3015425075-2022-00039
• Device Sequence Number: 5727938
• Product Code: GZB
• UDI-Device Identifier: 00812537035444
• UDI-Public: 01008125370354441121071310M1706M6
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 07/11/2022

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 Model Number: 74001
• Device Catalogue Number: 74001
• Device Lot Number: M1706 / M6219
• 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: 06/27/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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