MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT MEDICAL ABBOTT NEUROSPHERE DRG; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Codes	Pain (1994); Cancer (3262)
Type of Reportable Event	Serious Injury
Event or Problem Description
In 2012, i was diagnosed with bone cancer, requiring removal and replacement of several bones.Since then, i have lived with chronic pain.On the advice of my pain specialist, i agreed to have an abbott nerve stimulator implanted in (b)(6) 2022, but only after confirming the device and leads were mri-safe.In 2024, i learned of another abbott nerve stimulator using different technology that could be used alongside the first.Abbott representative (b)(6) and the implanting physician, dr.(b)(6), assured me that both devices and their leads were mri-safe.This later proved to be false.In (b)(6) 2025, i was diagnosed with colorectal cancer.My oncology team required an mri for staging, but when i attempted to place the stimulators into mri mode, the system would not allow it.The abbott representative initially claimed there was a workaround, but repeated attempts failed.When i contacted abbott corporate technical support directly, i was informed that patients with two abbott nerve stimulators are categorically prohibited from undergoing mri scans due to the risk of lead overheating and burns.This restriction is clearly stated in abbott's internal documentation, but was possibly ignored by (b)(6).Compounding the issue, dr.(b)(6) has refused to remove the devices due to the risk of spinal injury.A second pain specialist is also reluctant because of dr.(b)(6)'s unusual implant technique.A spinal surgeon would be required to remove the devices by splitting my vertebrae, a procedure not covered by insurance.As a result, i am in a dangerous medical situation.Accurate cancer staging/restaging is essential to determining treatment and remission, yet mri is not an option.I now face repeated invasive testing requiring anesthesia, with increased risks of bleeding and infection, to which i am prone.Device information: abbott proclaim, model 3660 abbott neurosphere drg, model 3875.Patient code: 1994, 3262.Device code: 3015.Ref report: mw5183835.

• Brand Name: ABBOTT NEUROSPHERE DRG
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT MEDICAL
• MDR Report Key: 24363670
• Report Number: MW5183836
• Device Sequence Number: 9595897
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT PROCLAIM, MODEL 3660.; AMLODIPINE.; DULOXOTINE.; TYLENOL.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian, White