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Sprint Quattro Secure S® 6935M49 (UDI 00643169309753)Recalls & reported problems

Medtronic, Inc. · LEAD 6935M49 USA DF4 EN NG ACI · Class 3 · Implant

All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169309753), received between Jul 20, 2017 and Oct 6, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Over-Sensing” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Over-Sensing3
  • Capturing Problem1
  • Decreased Sensitivity1
  • Impedance Problem1
  • Low impedance1
  • Signal Artifact/Noise1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 6, 2022Signal Artifact/Noise; Over-Sensing; Capturing Problem; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Capturing Problem; Impedance Problem

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD ELEVATED THRESHOLDS, ELEVATED IMPEDANCE, AND OVERSENSING OF NOISE WAS NOTED. THE PATIENT ALSO CALLED TO REPORT THAT THE LEAD WAS FAILING. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15556691 ↗
  • MalfunctionFeb 5, 2020Low impedance; Low impedance

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED LOW PACING IMPEDANCE. IT WAS NOTED THAT THE IMPEDANCE LEVEL APPEARS TO BE CHRONICALLY LOW. FOLLOW UP WAS CONDUCTED AND NO REPROGRAMMING HAS BEEN COMPLETED AT THIS TIME. THE LEAD 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 9673827 ↗
  • InjuryJan 13, 2020Over-Sensing; Decreased Sensitivity; Over-Sensing; Decreased Sensitivity

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 9584449 ↗
  • InjuryJul 20, 2017Over-Sensing; Over-Sensing

    IT WAS REPORTED A RIGHT VENTRICULAR LEAD ALERT SHOWED THE LEAD DISPLAYED HIGH RATE NON-SUSTAINED EPISODES AND THE SENSING INTEGRITY COUNTER WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS LEARNED THERE WAS POSSIBLE OVER-SENSING AND THE PATIENT¿S EPISODES WERE FAST AND IRREGULAR. RE-PROGRAMMING WAS PERFORMED, THE LEAD REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6729831 ↗

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Sources and updates

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