STERILE PermaLoc Electrode, 60cm 21-0017-99Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852184003144), received between Sep 4, 2018 and Oct 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT CONTACTED SYNAPSE TO INFORM OF AN ABSCESS AT THE ELECTRODE EXIT SITE. DURING A PREVIOUS COMPLIANT WHERE DAMAGED WIRES WERE REPAIRED FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT WAS NOT CARING FOR THE EXIT SITE AS DIRECTED IN THE IFUS. PATIENT WAS REMINDED TO FOLLOW THE CARE INSTRUCTIONS FOR THE EXIT SITE AS DETAILED IN THE IFUS. SYNAPSE ADVISED PATIENT TO CONTACT THEIR SURGEON TO PROVIDE MEDICAL GUIDANCE ON TREATMENT. PATIENT FOUND A LOCAL SURGEON WHO COULD ADDRESS THE ABSCESS AND RELOCATE THE ELECTRODES TO A NEW EXIT SITE. SURGERY WAS CONDUCTED (B)(6) 2025 TO RELOCATE THE ELECTRODES USING ULTRASOUND. ELECTRODE EXIT SITE WAS RELOCATED TO A LOCATION AWAY FROM THE ABSCESS. A NEW INDIFFERENT ELECTRODE WAS TUNNELED AT THE NEW ELECTRODE EXIT SITE. ELECTRODES WERE CRIMPED WITH NEW SOCKETS AND PLACED IN NEW ELECTRODE CONNECTOR. A BOOT WAS PLACED ON THE CONNECTOR AND FILLED WITH SILICONE, PER THE IFUS. ELECTRODES WERE TESTED AND THE SYSTEM FUNCTIONED PROPERLY.

  Patient problems: Abscess

  MAUDE report 23423935 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS AN ACTIVE MILITARY MEMBER STATIONED IN (B)(6). HE HAD A "RED STREAK" FROM THE EXIT SITE OF HIS PERCUTANEOUS IMPLANT, WHICH RAN UP HIS CHEST AREA. HE WAS TREATED FOR AN INFECTION AT A MILITARY HOSPITAL IN (B)(6) WHERE HE WAS GIVEN ANTIBIOTICS. HE RETURNED TO (B)(6) AND THE INFECTION CONTINUED. HE CONTACTED HIS FOLLOWING PHYSICIAN AT THE UNIVERSITY OF (B)(6) WHERE HE LIVES AND WHERE HIS FOLLOW UP WAS BEING DONE (HE WAS IMPLANTED AT (B)(6) MEDICAL CENTER). HIS PHYSICIAN INSTRUCTED HIM TO STOP TAKING THE ANTIBIOTICS AND TO CALL HIM IF THE INFECTION CONTINUED. THE INFECTION DID NOT CLEAR UP AND THE PATIENT RETURNED TO UNIVERSITY OF (B)(6) WHERE HIS PHYSICIAN DECIDED TO REMOVE THE DEVICE. THE PATIENT WAS EXPLANTED SOME TIME IN (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 7844352 ↗