Sprint Quattro Secure S® 6947M62Recalls & reported problems
Medtronic, Inc. · LEAD 6947M62 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
- 3
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169550957), received between Nov 7, 2018 and Sep 6, 2024 — classified as 1 death, 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Over-Sensing” (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.
Reports received per month
Most reported problems
Device problems
- Over-Sensing2
- Adverse Event Without Identified Device or Use Problem1
- Impedance Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiomyopathy1
- Congestive Heart Failure1
- Renal Failure1
- Sepsis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem
IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157526 ↗MalfunctionJun 26, 2024Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. ANOTHER LIA WAS TRIGGERED NINETEEN DAYS LATER DUE TO SIC AND HIGH-RATE NON-SUSTAINED EPISODES. ADDITIONALLY, IT WAS NOTED THAT THERE WAS VARIABLE R-WAVE MEASUREMENTS AND RV LEAD OVERSENSING THAT WAS NOTED ON STORED ELECTROGRAMS (EGM). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19621116 ↗DeathNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT IS DECEASED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS RETURNED WITH INFORMATION INDICATING THE PATIENT IS DECEASED AND THE CAUSE OF DEATH AS CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, RENAL FAILURE AND SEPSIS. ADDITIONAL INFORMATION RELATED TO THE SOURCE OF THE SEPSIS WAS REQUESTED AND NOT RECEIVED.
Patient problems: Cardiomyopathy; Congestive Heart Failure; Renal Failure; Sepsis
MAUDE report 8045914 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page