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DBS ™ 3391S-40Recalls & reported problems

Medtronic, Inc. · LEAD 3391S-40 PSYCH DBS OCD HDE EMAN · Class f · Implant

All models of DBS (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169313552), received between Jun 9, 2017 and Jun 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Break1
  • Device Damaged Prior to Receipt by User1
  • Device Operates Differently Than Expected1
  • High impedance1
  • Impedance Problem1
  • Low impedance1
  • Peeled/Delaminated1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 9, 2017Break; High impedance; Peeled/Delaminated; Device Damaged Prior to Receipt by User; Low impedance; Device Operates Differently Than Expected; Impedance Problem; Appropriate Device Problem Term/Code Not Available; Break; High impedance; Peeled/Delaminated; Device Damaged Prior to Receipt by User; Low impedance; Device Operates Differently Than Expected; Impedance Problem; Appropriate Device Problem Term/Code Not Available

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THE LEAD SEEMED MORE STIFF THAN THE OTHERS IMPLANTED THAT DAY. WHEN THE IMPEDANCES WERE CHECKED DURING IMPLANT ELECTRODE 3 SHOWED OUT OF RANGE LOW < 50. THE HEALTHCARE PROFESSIONAL (HCP) THEN PULLED THE ELECTRODE OUT OF THE EXTENSION AND WIPED IT OFF TWICE. THEY NOTICED THERE WAS A SMALL WIRE COMING OUT OF THE LEAD BY THE ELECTRODE. THEY THEN PLACED THE LEAD BACK IN THE EXTENSION AND DID THE TEST AGAIN IN THAT ELECTRODE THEN SHOWED OVER 10 ,000. THE HCP DID NOT WANT TO REMOVE THE LEAD FROM THE EXTENSION ANOTHER TIME AND THEY FELT IT WOULD DAMAGE THE INTEGRITY OF THE LEAD EVEN MORE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6630816 ↗

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Sources and updates

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