DBS™ 3391S-40Recalls & reported problems
Medtronic, Inc. · LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN · Class f · Implant
All models of DBS (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000274412), received between Oct 27, 2025 and Jan 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).
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
Device problems
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT OUT OF BOX/PRIOR TO USE IN A PATIENT WHO WAS UNDERGOING A DEEP BRAIN STIMULATION PROCEDURE. THE LEAD WAS NEVER IMPLANTED AND IT WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003836 ↗MalfunctionOct 27, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT PRIOR TO USE IN A PATIENT WHO WAS UNDERGOING A DEEP BRAIN STIMULATION PROCEDURE. THE LEAD WAS NEVER IMPLANTED AND IT WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393566 ↗
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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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