NA 6707-15 (UDI 00613994793942)Recalls & reported problems
Medtronic, Inc. · LEAD 6707-15 US MKT · Class 3 · Implant
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 00613994793942), received between Oct 10, 2017 and Nov 13, 2018 — classified as 1 injury, 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Low impedance1
- Mechanical Problem1
Patient problems
- Muscle Stimulation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2018Fracture; Fracture
A LEAD ADAPTOR APPARENTLY PREVIOUSLY ASSOCIATED WITH THE RV LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8067353 ↗InjuryOct 10, 2017Mechanical Problem; Low impedance; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Low impedance; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. THE PACE/SENSE RV COIL AND THE SUPERIOR VENA CAVA (SVC) COIL WERE REVERSED IN THE DEVICE AND THE PACE/SENSE PINS WERE ALSO REVERSED IN THE LEAD ADAPTOR. THE POCKET WAS OPENED AND THE LEAD AND THE ADAPTOR WERE PLACED IN THE PROPER POSITIONS IN RELATION TO THE DEVICE AND RV/SVC COILS. THE ADAPTOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Muscle Stimulation
MAUDE report 6936272 ↗
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