Sprint Quattro Secure® 6947M97Recalls & reported problems
Medtronic, Inc. · LEAD 6947M97 DF4 ACTIVE DC US EN · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure (10)
Data updated Oct 16, 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 00643169082304), received between Feb 8, 2018 and Sep 26, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
- High impedance1
- Inappropriate/Inadequate Shock/Stimulation1
- Over-Sensing1
Patient problems
- No Known Impact Or Consequence To Patient1
- 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.
InjurySep 26, 2018Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT HEARING A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD AND THEN THE ¿LEAD BROKE¿ AND SHOCKED THE PATIENT. A FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROVIDER YIELDED THAT THE RV LEAD HAD FRACTURED AND THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO OVERSENSING ON THE RV LEAD. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 7913039 ↗InjuryFeb 8, 2018Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNDEFINED SUPERIOR VENA CAVA (SVC) IMPEDANCE AND THE SVC HAD FRACTURED AFTER A DEVICE CHANGEOUT. THE SVC PORTION OF THE LEAD WAS PROGRAMMED OFF AND DEFIBRILLATION THRESHOLDS TESTING WAS SUCCESSFUL. THE REMAINDER OF THE LEAD IS STILL 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 7253784 ↗
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- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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