SPRINT QUATTRO SECURE® DXAC/DSP 694775 (UDI 00643169535954)Recalls & reported problems
Medtronic, Inc. · LEAD 694775 SPRINT QUATTRO US SI MCRD · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · SPRINT QUATTRO SECURE DXAC/DSP (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169535954), received between Nov 25, 2019 and Jan 7, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Capture” (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
- Failure to Capture1
- Fracture1
- Inappropriate/Inadequate Shock/Stimulation1
- Over-Sensing1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2021Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THE CLINICIAN SUSPECTED LOSS OF CAPTURE FOR NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THE RIGHT VENTRICULAR (RV) LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11131577 ↗InjuryNov 25, 2019Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS BEEN CAPPED AND REPLACED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 9371720 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
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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