Sprint Quattro Secure S® 6947M97Recalls & reported problems
Medtronic, Inc. · LEAD 6947M97 SPRINT US DF4 MCRD 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169550971), received between Apr 10, 2018 and Apr 1, 2019 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Capturing Problem2
- Decreased Sensitivity2
- Device Dislodged or Dislocated2
- Over-Sensing2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2019Over-Sensing; Decreased Sensitivity; Capturing Problem; Device Dislodged or Dislocated; Over-Sensing; Decreased Sensitivity; Capturing Problem; Device Dislodged or Dislocated
IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A DECREASE IN R WAVES, AND INCREASE IN THRESHOLDS AND A DISLODGEMENT WAS CONFIRMED BY X-RAY. THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8470787 ↗InjuryApr 10, 2018Over-Sensing; Decreased Sensitivity; Capturing Problem; Device Dislodged or Dislocated; Over-Sensing; Decreased Sensitivity; Capturing Problem; Device Dislodged or Dislocated
IT WAS FURTHER REPORTED THAT THE RV LEAD WAS PARTIALLY EXPLANTED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7417879 ↗
Other permanent pacemaker Electrode devices
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- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 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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