Spencer Probe Depth Electrode SD08R-SP05X-000 (UDI 00841823107695)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841823107695), received between Jan 31, 2020 and Mar 30, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Signal Artifact/Noise; Signal Artifact/Noise

  ON MARCH 2, 2023, AD-TECH'S CUSTOMER SUPPORT MANAGER WAS CONTACTED VIA EMAIL, BY A CUSTOMER STATING THAT TWELVE (12) DEPTH ELECTRODES WERE PLACED IN A PATIENT ON (B)(6) 2023. THE PATIENT WAS THEN BROUGHT BACK INTO SURGERY ON POST OP DAY 3 TO HAVE EIGHT (8) ELECTRODES REPLACED ON (B)(6) 2023 DUE TO INCREASING ARTIFACT ON THE EEG. THERE WAS NO INJURY TO THE PATIENT, HOWEVER A SECOND SURGERY WAS NEEDED FOR REPLACEMENT OF ELECTRODES. ON MARCH 23, 2023, FDA SENT AD-TECH THE ASSOCIATED USER FACILITY REPORT (B)(4), WHICH HAD BEEN SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16652791 ↗
• MalfunctionMay 16, 2022Material Separation; Material Separation

  DURING EXPLANT, A DEPTH ELECTRODE FRAGMENT WAS RETAINED. EXTRA IMAGING AND UNPLANNED PROCEDURES WERE NECESSARY TO REMOVE THE FRAGMENT. THERE WAS NO PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414105 ↗
• MalfunctionSep 18, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER STATED UPON TAKING THE ELECTRODE OUT OF THE PACKAGE THE TIP WAS FOUND TO BE BENT. THE ELECTRODE WAS NOT USED, A DIFFERENT ELECTRODE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10554710 ↗
• MalfunctionJan 31, 2020Inaccurate Information; Inaccurate Information

  ON APRIL 15, 2019, AN AD-TECH CLINICAL SPECIALIST REPORTED THAT DURING A CASE THEY ATTENDED THE SURGEON ENCOUNTERED AN ISSUE AFTER IMPLANTING FOUR AD-TECH DEPTH ELECTRODES. UPON INITIAL DEVICE TESTING SUBSEQUENT TO IMPLANTATION IT WAS IDENTIFIED THAT TWO OF THE DEVICES THAT WERE LABELED AS 8 CONTACT DEPTH ELECTRODES WERE IN FACT 6 CONTACT DEPTH ELECTRODES. THERE WAS NO IMPACT TO THE PATIENT DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9654450 ↗