MAUDE Adverse Event Report: ABBOTT MEDICAL SPINAL CORD STIMULATOR (SCS) NEUROSTIMULATION SYSTEM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 01/15/2024

Event Type  Injury  

Event Description

The reason for call was caller said pt needed mri because hcp believed infection may have started forming around implant site.Pt was admitted to emergency room for fevers and back pain on (b)(6) 2024.Upon further inquiry, the caller said the scs device was from abbott.Model numbers provided on phone call were: 3186, 3086, and 3186.Pt name was (b)(6) (dob: (b)(6) 1966).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPINAL CORD STIMULATOR (SCS) NEUROSTIMULATION SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18650712
• MDR Text Key: 334757174
• Report Number: MW5151087
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1