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

Model Number 71005

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 12/11/2021

Event Type  Injury  

Event Description

Patient had his ipg implanted on (b)(6) 2020.He came in for a wound check on (b)(6) 2020 and it was healing well without any signs of infection.On (b)(6) 2020, patient presented for an unscheduled visit stating he developed a rash with itching all across his back the evening of (b)(6) 2020.The wound was checked again without any signs of infection.The physician recommended benadryl to manage the rash and itching.He returned on (b)(6) 2020, stating the rash worsened.He was prescribed a medrol dos pak.Subject returned to the office on (b)(6) 2020 for evaluation.His rash had improved but his itchiness continued.He was referred to an allergist for testing of possible allergic reaction to the device or anything used during the implant to account for the continued reaction.Subject returned on (b)(6) 2020 reporting his symptoms have still not resolved.Subject had the ipg device removed on (b)(6) 2020.As of (b)(6) 2020 the wound is healing well.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 11219312
• MDR Text Key: 258630202
• Report Number: 3015425075-2021-00004
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001119121617201215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2021

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: No Information
• Device Expiration Date: 12/15/2020
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention