MAUDE Adverse Event Report: UNKNOWN UNKNOWN LEAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported in a literature article (feldman, a.T., goff, b.J.Epidural analgesia to facilitate scs trial after previous trial failed due to intolerable pain (10678).North american neuromodulation society 19th annual meeting.2015.347.) that the patient still reported focal thoracic spine discomfort without dermatomal bands wrapping anteriorly or distal neurological signs/symptoms.This pain persisted throughout their otherwise successful week-long trial.Discomfort was relieved with lead removal, and thoracic spine mri demonstrated no anomaly.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN LEAD
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532706
• MDR Text Key: 321133495
• Report Number: MW5139613
• 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
• Patient Sequence Number: 1