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

Model Number 71002

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/10/2020

Event Type  Injury  

Event Description

During a visit on (b)(6) 2020, patient reported that she was experiencing an increasing frequency of disconnections with the device.An x-ray, performed during visit, revealed the ipg had rotated approximately 90 degrees.A revision surgery was performed on (b)(6) 2020 to relocate the ipg.

• 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: 10180630
• MDR Text Key: 195982179
• Report Number: 3015425075-2020-00007
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537031071
• UDI-Public: 01008125370310711119050717200506
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

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: 05/06/2020
• Device Model Number: 71002
• Device Catalogue Number: 71002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: 47 YR