Selectsecure™ 383049 (UDI 00613994520784)Recalls & reported problems
Medtronic, Inc. · LEAD 383049 SELECTSECURE ACT BI SIL US · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994520784), received between Oct 24, 2019 and Aug 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Under-Sensing2
- Pacing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited under sensing resulting in misclassification of episode type, unnecessary pacing at times and termination of Atrial Tachycardia (AT)/Atrial Fibrillation (AF) detected event(s) in progress. It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in over pacing. It was reported that the RV lead was under sensing in blanking, resulting in over pacing. The Implantable Pulse Generator (IPG) system remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450908 ↗MalfunctionOct 24, 2019Under-Sensing; Under-Sensing
IT WAS REPORTED THAT UNDERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD ON CURRENT ELECTROGRAMS (EGM) AND HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RA AND RV LEADS 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 9232433 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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