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

Model Number 74001

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/27/2022

Event Type  Injury  

Event Description

Nalu was made aware of a planned revision on (b)(6) 2022.On (b)(6) 2021 the patient reported that when sitting down, the nalu external transmitter modules (etms) will disconnect and start beeping.It was noted that the patient's skin is very loose and the external disc moves easily on the skin when the patient changes positions.The nalu representative attempted multiple troubleshooting strategies.Ultimately the physician and patient decided to revise the implant to a different style that does not require external components.Nalu became aware of this decision on (b)(6) 2022.No other information is available as to status or outcome 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; carlsbad 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: 14982692
• MDR Text Key: 295674985
• Report Number: 3015425075-2022-00039
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537035444
• UDI-Public: 01008125370354441121071310M1706M6
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74001
• Device Catalogue Number: 74001
• Device Lot Number: M1706 / M6219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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): Other