MAUDE Adverse Event Report: STIMWAVE SCS ELECTRODES; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the electrodes couldn't stay in place in connective tissue.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SCS ELECTRODES
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): STIMWAVE
• MDR Report Key: 17529354
• MDR Text Key: 321450731
• Report Number: MW5136282
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1