Current® DR RF (REF 2207-36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734501927), received between Aug 3, 2018 and Nov 11, 2021 — classified as 4 deaths, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR A NORMAL GENERATOR CHANGE PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A WIRE PROTRUDING OUT FROM THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER CONSEQUENCES. THE PATIENT WAS RECOVERING POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795703 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 07/29/2016. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12526244 ↗
• MalfunctionMay 18, 2021Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A SHORT CHARGE TIME. FURTHER INVESTIGATION REVEALED THAT THE DEVICE ABORTED THERAPY DUE TO LOW HIGH VOLTAGE IMPEDANCE ON THE PATIENT'S RIGHT VENTRICULAR LEAD. SUBSEQUENT THERAPY WAS DELIVERED WITH THE DEVICE HAVING CHARGED FOR THERAPY DELIVERY FROM THE PREVIOUS EPISODE PRIOR TO THERAPY BEING ABORTED RESULTING IN THE SHORT CHARGE TIME. THE DEVICE WAS EXPLANTED FOR REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR AND REPLACED. THE PATIENT WAS STABLE PRIOR, DURING, AND AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842087 ↗
• MalfunctionFeb 15, 2021Stretched; Stretched

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-08697. IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING EPISODES OF SHOCK. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR - RV LEAD EXHIBITED OVERSENSING CAUSING INAPPROPRIATE SHOCK. DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CAN WAS FOUND TO BE SWOLLEN. WHILE ATTEMPTING TO EXPLANT THE RV LEAD, THE PROXIMAL PORTION OF THE SHOCKING COIL BROKE AND WAS LEFT IMPLANTED. THE ICD AND REMAINING PORTION OF THE RV LEAD WAS EXPLANTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328002 ↗
• DeathFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 9712687 ↗
• DeathOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-14126. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-14128.

  Patient problems: Death

  MAUDE report 9142362 ↗
• MalfunctionJun 7, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. UPON REVIEW, THE PACEMAKER EXHIBITED BACKUP VVI OPERATION. THE PATIENT CAME INTO CLINIC AND THE BACKUP OPERATION WAS CONFIRMED. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8680706 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENT WITH SWELLING AROUND THE IMPLANT SITE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE AND TOLERATED THE PROCEDURE WELL.

  Patient problems: Swelling

  MAUDE report 8651919 ↗
• MalfunctionApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Information

  MAUDE report 8547539 ↗
• MalfunctionMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Information

  MAUDE report 8462226 ↗
• DeathFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED AT THE HOSPITAL. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Death

  MAUDE report 8323475 ↗
• DeathFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS CARDIAC RELATED.

  Patient problems: Death

  MAUDE report 8319041 ↗
• InjuryJan 30, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED AND REPLACED DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. UPON REVIEW OF THE DEVICE DIAGNOSTICS, IT WAS NOTED THE THERE WAS NO EVIDENCE OF BATTERY OR HARDWARE MALFUNCTION. IT WAS SUSPECTED THAT THE PROGRAMMERS USED TO DIAGNOSE BATTERY LONGEVITY MAY HAVE OVERESTIMATED THE AMOUNT OF TIME AVAILABLE UNTIL THE DEVICE REACHES END OF LIFE. THE MISLEADING DATA CAUSED THE DEVICE TO APPEAR TO HAVE A FASTER THAN NORMAL BATTERY DRAINAGE. NO PATIENT SYMPTOMS WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8291339 ↗
• InjuryJan 4, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING A VIBRATORY NOTIFIER. IT WAS THEN DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PREMATURELY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2018. DURING THE PROCEDURE, FLUOROSCOPY REVEALED THAT THE RIGHT VENTRICULAR LEAD HAD AN INSULATION BREACH AND WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE AND WAS DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219712 ↗
• MalfunctionDec 20, 2018Low impedance; Low impedance

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8187098 ↗
• InjurySep 11, 2018Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR A DEVICE CHANGE OUT DUE TO A VARIABLE R-WAVE SENSING THAT HAD BEEN NOTED PRIOR. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE PRIOR DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865642 ↗
• MalfunctionAug 10, 2018Data Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW OF ELECTROGRAMS, THE IMPLANTABLE CARDIAC DEFIBRILLATOR EXHIBITED A DIAGNOSTICS ISSUE. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABLE PRE, DURING, AND AFTER THE FOLLOW UP VISIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774469 ↗
• MalfunctionAug 3, 2018Misconnection; Misconnection

  DURING A REPLACEMENT PROCEDURE FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE SET SCREW COULD NOT BE LOOSENED ON THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7747799 ↗