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NA 5071-15Recalls & reported problems

Medtronic, Inc. · LEAD 5071-15 PACING EPI SCREW-IN US · Class 3 · 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 00681490124225), received between Nov 9, 2021 and Nov 9, 2021 — 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
  • High impedance1
  • Signal Artifact/Noise1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 9, 2021Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A LOOSE SET SCREW THAT CAUSED RIGHT VENTRICULAR (RV) LEAD OVERSENSING OF NOISE AND HIGH AND UNDEFINED IMPEDANCE. IT WAS ALSO REPORTED THAT THE RV LEAD HAD FRACTURED. THE IPG AND RV LEAD WERE INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12779475 ↗

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