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	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was initially implanted on (b)(6) 2019.On (b)(6) 2019 an x-ray revealed ipg movement but this did not cause any issues with therapy but caused minor inconvenience in terms of disconnections with the therapy disc.Recently, after 1-year of device use, the patient continued to receive good clinical benefit, but expressed a desire to have her device repositioned to improve connectivity with her therapy discs.Subsequent revision surgery occurred on (b)(6) 2020.On (b)(6) 2020 patient confirmed disconnections are no longer an issue post-revision and x-rays reveal no change in lead position.
Additional Manufacturer Narrative
B5: describe event or problem additional.H2: additional information.H10: summary of corrections and additions in this supplemental.
Event or Problem Description
On (b)(6) 2020, physician removed leads from the patient's epidural space, and coiled them near the implantable device.The physician performed a re-implantation of the leads on (b)(6) 2020.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite #100; carlsbad, ca
• MDR Report Key: 10426971
• Report Number: 3015425075-2020-00009
• Device Sequence Number: 14183985
• Product Code: GZB
• UDI-Device Identifier: 00812537030517
• UDI-Public: 01008125370305171118110217191102
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 11/02/2019
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR