NeuroSphere™ 3875Recalls & reported problems
St. Jude Medical, Inc. · Patient Controller · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067046970), received between Nov 8, 2023 and Nov 8, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2023
REPORTER CALLED TO REPORT AN ISSUE WITH HIS IMPLANTED PROCLAIM NEUROSTIMULATOR. HE FIRST RECEIVED HIS IMPLANT FOR PAIN RELIEF ON (B)(6) 2018. IT WAS REVISED ON (B)(6) 2020 AND WAS REASSURED THAT THE REVISION ALLOWED IT TO BE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE. HE RECENTLY RECEIVED A LETTER FROM ABBOTT ABOUT A RECALL ON HIS DEVICE ALTHOUGH IT IS STILL CONSIDERED COMPATIBLE WITH THE MRI PROCEDURE. REPORTER NOW NEEDS A LOWER LUMBAR MRI BUT IS NOT ABLE TO GET ONE DUE TO HIS RECALLED DEVICE. HE HAS ATTEMPTED TO GET AN MRI AT FIVE DIFFERENT FACILITIES BUT ALL OF THEM HAVE TURNED HIM DOWN DUE TO THE NOTICE OF HIS RECALLED NEUROSTIMULATOR. HIS REGULAR FACILITY OF CARE HAS NOTIFIED HIM THAT HE CAN NO LONGER GET TREATMENT FROM THEM DUE TO THE RECALLED DEVICE. REPORTER STATES THAT HE IS IN CONSTANT PAIN, AND HAS BEEN TOLD THAT IN ORDER TO RESTORE THE TREATMENT THAT HE NEEDS, HE WOULD HAVE TO HAVE ANOTHER SURGICAL PROCEDURE FOR AN UPDATED DEVICE THAT IS MRI COMPATIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18102337 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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