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NA 365538Recalls & reported problems

Medtronic, Inc. · ACCY KIT 365538 TUNNELING TOOL · Class 1

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 00643169986503), received between Sep 10, 2018 and Mar 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 25, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH AN NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE HCP HEARD A SNAP WHEN TUNNELING, TIP BROKE OFF. THERE WERE NO KNOWN CAUSES. X-RAY WAS DONE TO FIND THE TIP BUT WAS NOT SUCCESSFUL. THE ISSUE WAS RESOLVED. THE HCP HAD NO FURTHER INFORMATION. THE DEVICE WAS RETURNED FOR ANALYSIS. NO SYMPTOMS AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9879205 ↗
  • MalfunctionSep 10, 2018Break; Break

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE HCP WAS USING THE PASSER TO PASS THE EXTENSIONS FROM THE LEFT PECTORAL POCKET TO THE LEFT SIDE OF THE HEAD. THE REP REPORTED THAT THE PASSER THAT PASSED BOTH EXTENSIONS BROKE NEAR THE PLACE WHERE THE BARRELS FIT INTO THE STYLET. THE STYLET PLASTIC BROKE. THE HCP HAD TO MAKE AN EXTRA INCISION TO RETRIEVE THE EXTENSIONS AND TOOK AN EXTRA 20 MINUTES TO DO THE PROCEDURE. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7860132 ↗

Other INSTRUMENT, SURGICAL, NON-POWERED devices

All INSTRUMENT, SURGICAL, NON-POWERED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.