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NA 6981MRecalls & reported problems

Medtronic, Inc. · ACCESS 6981M KIT EXTENDER UNI IS-1 · Class 2 · Implant

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 00681490153553), received between Jan 9, 2019 and Jan 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

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.

  • InjuryJan 9, 2019Fracture; Fracture

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS IMPLANTED USING A LEAD EXTENDER. THERE WAS A FRACTURE NOTED IN EITHER THE LEAD OR THE EXTENDER, IT WAS NOT ABLE TO BE DETERMINED WHERE THE FRACTURE OCCURRED. THE EXTENDER AND LEAD WERE INITIALLY PROGRAMMED OFF, THEN CAPPED, AND THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8231940 ↗

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