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SelectSecure™ 383074 (UDI 00613994119957)Recalls & reported problems

Medtronic, Inc. · LEAD,383074,BIP,CATH DELIV,4FR,74CM,EN · Class 3 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994119957), received between Feb 8, 2018 and Feb 22, 2021 — classified as 2 injuries, 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
  • Capturing Problem1
  • High Capture Threshold1
  • Impedance Problem1
  • Under-Sensing1

Patient problems

  • Chest Pain1
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 22, 2021Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH PACING THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11357379 ↗
  • MalfunctionJan 26, 2021Under-Sensing; Under-Sensing

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN, TIGHTNESS AND FREQUENT ECTOPY (DISTURBANCE OF THE CARDIAC RHYTHM). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RIGHT ATRIAL (RA) LEAD EXHIBITED LEAD POSITION CHECK FAILURE AND HIGH THRESHOLDS. THE RA AND THE RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Chest Pain

    MAUDE report 11228494 ↗
  • InjuryFeb 8, 2018Break; Impedance Problem; Break; Impedance Problem

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD RISING IMPEDANCES. UPON INSPECTION, IT WAS NOTED THAT THE RV LEAD INSULATION WAS DAMAGED. THE LEAD WAS REPAIRED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7254972 ↗

Other Permanent defibrillator electrodes devices

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