Current® 1107-36Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillatorVVEV VVIR · Class 3 · Implant
All models of Current (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734502184), received between Aug 9, 2018 and Mar 14, 2021 — classified as 2 injuries, 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 16, 2026.
Most reported problems
Device problems
- Failure to Capture1
- Inappropriate or Unexpected Reset1
- Over-Sensing1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI MODE. A DEVICE DOWNLOAD OR RESTORATION WAS NOT PERFORMED DUE TO THE DEVICE'S AGE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT¿S CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478774 ↗MalfunctionJul 8, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST PACED T WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10247662 ↗InjuryAug 9, 2018Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOSS OF CAPTURE. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7767839 ↗
Other Pulse generator, permanent, implantable devices
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- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 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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