MAUDE Adverse Event Report: UNKNOWN UNKNOWN 8 CONTACT SCS PERCUTANEOUS EPIDURAL LEADS; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number Q6 EDGE

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported in a literature article (lamer, t.J., gazelka, h.M., keller-ross, m.Spinal cord stimulation fails to block experimental lschemic pain in healthy adult volunteers (10250).North american neuromodulation society 19th annual meeting.2015.296.) that three separate trials were performed and there was no significant difference between the control group and the scs treatment groups.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN 8 CONTACT SCS PERCUTANEOUS EPIDURAL LEADS
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531873
• MDR Text Key: 321147077
• Report Number: MW5138784
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: Q6 EDGE
• Patient Sequence Number: 1