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

Model Number 11002-040

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/02/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a migration of the implanted leads.The scs system was implanted into the patient on (b)(6) 2019.It was determined to perform revision surgery on the patient on (b)(6) 2019.Revision surgery was performed on the patient on (b)(6) 2019.During the revision surgery it was determined that the reason for the lead migration was that the suture had become untied from one of the lead anchors.During the revision surgery, the sutures were properly secured to the lead anchors and the leads were placed in the correct place.

• Brand Name: IPG (INTEGRATED , DUAL 8, 40CM)
• 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: 9246408
• MDR Text Key: 167550746
• Report Number: 3015425075-2019-00005
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2019

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 Expiration Date: 11/05/2019
• Device Model Number: 11002-040
• Device Catalogue Number: 11002-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/28/2019
• 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: 63 YR
• Patient Weight: 72