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

Model Number 3875

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); Irritability (2421); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/01/2021

Event Type  Injury  

Event Description

The reporter called regarding st jude spinal cord stimulator for pain relief.The reporter mentioned the device implanted in 2017 has got stuck in mri mode settings.The reporter stated " i had to undergo few tests in (b)(6) 2021 during which the device was changed to mri mode after which the device got stuck in the setting and does not go back to the original settings.Also i had triple bypass surgery during which the device stopped working.It is causing me pain in my left hip and leg more than before, muscle spasm, irritation and hard to walk." the reporter has given complaint to the manufacturer with no positive response and is okay to be contacted for further information.

• Brand Name: ST JUDE SPINAL CORD STIMULATOR FOR PAIN RELIEF
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18595773
• MDR Text Key: 334088829
• Report Number: MW5150821
• 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: Patient
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3875
• Device Lot Number: 5899229
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG