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 Post Operative Wound Infection (2446)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

No lab testing or other test results have been made available to the firm to determine the nature of the infection and the patient admitted to being noncompliant with post-op antibiotics.Infection is a known and inherent risk of invasive procedures and this patient was potentially higher risk due to noncompliance.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023.On (b)(6) 2023 the firm became aware of a possible infection at the surgical incision site.Patient had been prescribed prophylactic antibiotics immediately after the implant, however the patient was discovered to have been noncompliant with that prescription.Additional antibiotics were prescribed upon discovery of possible infection and as of (b)(6) 2023 the patient initially appeared to be responding well and the incision site was healing.On (b)(6) 2023 the firm became aware that the patient had a full system explant performed on (b)(6) 2023 due to ongoing infection and failure to heal.The firm was not made aware of the procedure prior and was thus not in attendance.The explanted device was disposed by the medical facility at the time of the procedure.

• 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 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: 18116899
• MDR Text Key: 327880878
• Report Number: 3015425075-2023-00276
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123071017260710
• 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: 11/10/2023

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: 10/12/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other