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NA 355018 (UDI 00643169660076)Recalls & reported problems

Medtronic, Inc. · ACCY 355018 LEAD INTRODUCR KIT ISTIM US · Class 2

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 00643169660076), received between Apr 2, 2019 and Apr 2, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Insufficient Device Problem Information1

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.

  • MalfunctionApr 2, 2019Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE SHEATH PEELED BACK ON THE INTRODUCER DURING THE PROCEDURE. THERE WERE NO CONTRIBUTING FACTORS REPORTED. IT WAS REPLACED WITH A NEW INTRODUCER TO RESOLVE THE ISSUE. IT WAS REPORTED THE AFFECTED PRODUCT HAD BEEN DISCARDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8475117 ↗

Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices

All STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices →

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