Sprint Quattro Secure S™ 693552Recalls & reported problems
Medtronic, Inc. · LEAD 693552 US EN · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994446336), received between Nov 4, 2019 and Jun 21, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Capturing Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Capturing Problem2
- High Capture Threshold2
- High impedance2
- Impedance Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Bradycardia1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2024High impedance; High impedance
IT WAS ALSO REPORTED THAT THE LV LEAD WAS TURNED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19585296 ↗InjuryMay 5, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. CAPTURE MANAGEMENT WAS PREVIOUSLY PROGRAMMED OFF, AND THE LEAD WAS LATER CUT AND PARTIALLY EXPLANTED DURING AN UPGRADE PROCEDURE, AND THE REMAINING PORTION OF THE LEAD WAS CAPPED AND REMAINS IN THE PATIENT. A NEW RV 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 16876589 ↗MalfunctionJul 22, 2020High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND GRADUALLY RISING PACING IMPEDANCE. THE PATIENT WILL BE CLOSELY MONITORED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10308082 ↗MalfunctionNov 4, 2019Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE LEAD WARNING TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN INCREASE IN RV COIL IMPEDANCES. 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 9273412 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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