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

Model Number 71005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

There are no reports of any external trauma to the incision site and no obvious cause for failure to heal.The firm has not been made aware of any cultures or testing to confirm or rule out infection at the incision.Failure to heal and wound dehiscence are known inherent risks of invasive procedures and there is no indication that the nalu device caused or contributed to the delayed healing.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023 to treat lower back pain.On (b)(6) 2024, the patient presented to the physician's office for a post-op wound check.The medical office determined that the surgical wound appeared to be failing to properly heal and beginning to dehisce.A surgical procedure was performed on (b)(6) 2024.Plan was to surgically debride and close the incision site.Per patient request, the implantable pulse generator (ipg) was also relocated during the procedure from the lower back, waist area up to the mid-back.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD 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: 18773880
• MDR Text Key: 336182153
• Report Number: 3015425075-2024-00059
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other