MAUDE Adverse Event Report: NALU MEDICAL INC. NALU NEUROSTIMULATION KIT (INTEGRATED , DUAL 8, 40 CM); SPINAL CORD STIMULATOR

Model Number 71002

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/01/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a migration of the implantable pulse generator (ipg) after the device was implanted into the patient.The scs system was implanted into the patient on (b)(6) 2019.The patient had an x-ray taken on (b)(6) , and after reviewing this xray, the ultrasound, and internal discussion it was determined that the ipg had migrated.On (b)(6) 2019 it was determined that revision surgery was required to fix the migration.

• Brand Name: NALU NEUROSTIMULATION KIT (INTEGRATED , DUAL 8, 40 CM)
• 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 ; 7608276463
• MDR Report Key: 9218977
• MDR Text Key: 169730039
• Report Number: 3015425075-2019-00004
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71002
• Device Catalogue Number: 71002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 54 YR
• Patient Weight: 67