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

Patient Problems Inadequate Pain Relief (2388); Paresthesia (4421)

Event Date 09/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 the patient underwent a procedure in which the spinal cord stimulator (scs) abbot device was explanted due to the device causing intolerable paresthesia and worsening back pain.The patient was implanted with a device manufactured by boston scientific device.The physician's name is dr.Colby beal, and the facility name is unknown.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18032344
• MDR Text Key: 327182021
• Report Number: MW5147433
• 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: 10/05/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2023
• Patient Sequence Number: 1