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NA 355018 (UDI 00613994729989)Recalls & reported problems

Medtronic, Inc. · ACC 355018 INTRODUCER KIT INTERSTIM US · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994729989), received between Apr 13, 2018 and Apr 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Shelf Life Exceeded” (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

  • Shelf Life Exceeded1

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.

  • InjuryApr 13, 2018Shelf Life Exceeded; Shelf Life Exceeded

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TEST PATIENT DURING AN INTRAOPERATIVE PROCEDURE. IT WAS REPORTED THAT A SURGEON WAS DOING A CASE FOR A PEDIATRIC SURGEON AT A HOSPITAL THAT ALL HCPS KNEW TO BE OFF LABEL. THE LEAD WAS PLACED IN THE PATIENT AND ALL ITEMS WERE OPENED BY THE CHARGE NURSE. EVERYTHING WAS PLACED WITHOUT AN EVENT HOWEVER PRIOR TO CLOSING, THE CHARGE NURSE POINTED OUT THAT THE LEAD WAS EXPIRED AND SO THE LEAD WAS PULLED AND A NEW LEAD WAS PLACED SUCCESSFULLY. ONCE THE CASE WAS OVER, THE CHARGE NURSE POINTED OUT THAT THEY HAD MADE AN ERROR AND IT WASN¿T THE LEAD THAT WAS EXPIRED BUT RATHER THE LEAD INTRODUCER KIT WAS EXPIRED. IT WAS STRESSED AGAIN BY THE REP THAT THE LEAD PLACED IN THE BODY WAS NEVER EXPIRED. IT WAS REPORTED THE PATIENT WAS FINE AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED. ON 2018-MAR-28, ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE PHYSICIAN WAS AWARE OF THE EVENT AND THAT THEY DIDN'T REQUIRE ANY FOLLOW UP. ON 2018-APRIL-03, ADDITIONAL INFORMATION WAS RECEIVED FROM

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7429483 ↗

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