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

Model Number 71004

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/20/2020

Event Type  Injury  

Event 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.

Manufacturer Narrative

B5: describe event or problem additional.H2: additional information.H10: summary of corrections and additions in this supplemental.

Event 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
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite #100; carlsbad, ca
• MDR Report Key: 10426971
• MDR Text Key: 203643295
• Report Number: 3015425075-2020-00009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537030517
• UDI-Public: 01008125370305171118110217191102
• Combination Product (y/n): N
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR