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

Model Number 71005

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/11/2020

Event Type  Injury  

Event Description

During a visit on (b)(6) 2020 and (b)(6) 2020, patient reported that she was experiencing decreased therapy with the device.Analysis of x-rays and ultrasounds of the device revealed movement from the original placement of the patient's lead.On (b)(6) 2020, physician removed the lead from patient's epidural space, and coiled them near the implantable device.He will wait at least 6 weeks before proceeding with re-implantation.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad, ca
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad, ca
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, ca ; 4482360
• MDR Report Key: 10426344
• MDR Text Key: 203530546
• Report Number: 3015425075-2020-00008
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537031101
• UDI-Public: 01008125370311011119102517201024
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2020

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 Expiration Date: 10/24/2020
• 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: 08/11/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR