MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FREELINK; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-5562-1
Health Effect - Clinical Codes	Failure of Implant (1924); Paralysis (1997); Anxiety (2328); Inadequate Pain Relief (2388); Electric Shock (2554)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I had the boston scientific spinal cord stimulator implanted (b)(6) 2020 due to chronic back pain.On (b)(6) 2021 the boston scientific spinal cord stimulator malfunctioned causing an electrocution episode.I felt the lead in my back malfunctioning and the device had to be shutdown to stop the electrocution state to subside.I was placed in a paralyzed state until the device was turned off.Upon turning off this device i was able to move, but it caused me to be in even more pain than before.I had to keep this device off until visiting with the boston scientific representative at the doctor's office.The representative tested the device and informed me to leave it at the new programmed module and it would be no need the work the remote to adjust the settings.I encountered more pain over the next few months.After speaking with the representative numerous times, i realized that the device wasn't in the on position.I reached out to my doctor and they inform me that we would need to remove the device and replace it with the abbott spinal cord stimulator.On december 15, the boston scientific spinal cord stimulator was removed, and the new abbott spinal cord stimulator was implanted.This device malfunctioned and caused me months on excruciating pain, physical, and mental anguishment.I had an x-ray performed and the results showed that the spinal cord stimulator leads were malfunctioning.According to the results the device needed to be replaced.

• Brand Name: FREELINK
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18256814
• Report Number: MW5148681
• Device Sequence Number: 18103041
• Product Code: LGW
• UDI-Device Identifier: 08714729953449
• UDI-Public: 0108714729953449
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/04/2020
• Device Model Number: SC-5562-1
• Device Catalogue Number: M365SC556210
• Device Lot Number: 175230
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FAMODINE.; GABAPENTIN.; HYDROCODONE.; IBROPROFEN.; MAGNESIUM.; QUENTIN.; SPINAL CORD STIMULATOR.; TIZANIDINE.; VITAMIN C.; WOMEN VITAMINS.
• Outcome Attributed to Adverse Event: Other; Disability; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American