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

Model Number 71002

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/26/2020

Event Type  Injury  

Event Description

Patient alleged device disconnects on (b)(6) 2020.Analysis of ultrasounds of the device and x-rays of the device revealed the patient had a rotated ipg.The rotated ipg is the root cause of the disconnects.Revision surgery was performed on (b)(6) 2020.

• Brand Name: IPG(INTEGRATED, DUAL 8, 40CM)
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 farady avenue; carlsbad, ca
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; carlsbad, ca
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; carlsbad, ca ; 4482360
• MDR Report Key: 9832597
• MDR Text Key: 189310545
• Report Number: 3015425075-2020-00002
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537031071
• UDI-Public: 01008125370310711118110517191105
• 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: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/17/2020

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: 11/05/2019
• Device Model Number: 71002
• Device Catalogue Number: 71002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 MO
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• 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
• Patient Age: 50 YR