Sprint Quattro Secure S™ DXAC/DSP 6935100 (UDI 00613994446121)Recalls & reported problems
Medtronic, Inc. · LEAD 6935100 US EN SI MCRD · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S DXAC/DSP (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00613994446121), received between Aug 10, 2021 and Aug 10, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
- High impedance1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2021Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation
IT WAS FURTHER REPORTED VIA FOLLOW-UP THAT THE LEFT SUBCLAVIAN COIL IS FRACTURED AND THAT THE PATIENT HAS RECEIVED INAPPROPRIATE THERAPY. THE LEAD WAS REPROGRAMMED WITH THE OBJECTIVE OF ELIMINATING INAPPROPRIATE THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)
MAUDE report 12301355 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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