Current® VR RF (REF 1207-36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05414734501941), received between Jun 20, 2018 and Sep 30, 2021 — classified as 2 deaths, 26 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Loose or Intermittent Connection; Use of Device Problem; Loose or Intermittent Connection; Use of Device Problem

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR AN UNRELATED PROCEDURE. UPON ATTEMPTING TO LOOSEN THE SET SCREW OF THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IT WAS OBSERVED THE WRENCH WOULD NOT FIT THE SCREW. THE PHYSICIAN ALSO EXPRESSED CONCERN ABOUT THE SILICONE PORT REMOVING TOO EASILY. THE ICD WAS EXPLANTED AND REPLACED IN THE SAME PROCEDURE WITHOUT ISSUE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555780 ↗
• InjurySep 22, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED IN CLINIC THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DISCOVERED IN BACKUP VVI OPERATION. THE PHYSICIAN EXPLANTED AND REPLACED THE ICD DUE TO LOW BATTERY STATUS AND END OF SERVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514132 ↗
• MalfunctionJun 9, 2021Over-Sensing; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-13111. NEW INFORMATION NOTED THAT THE PATIENT PRESENTED IN-CLINIC. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD NOISE WAS REPRODUCIBLE WITH POCKET MANIPULATION. THE PATIENT WAS SCHEDULED FOR A POTENTIAL RV LEAD REVISION. ON (B)(6) 2021 THE PATIENT PRESENTED FOR A LEAD REVISION. DURING THE PROCEDURE, INTERMITTENT LEAD NOISE WAS OBSERVED WHILE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS STILL IN THE POCKET. HOWEVER, ON REMOVAL OF THE DEVICE NO FURTHER NOISE WAS OBSERVED ON THE V SENSE CHANNEL. NUMEROUS ATTEMPTS WERE MADE TO REPRODUCE THE LEAD NOISE WITH MANIPULATION OF THE HEADER AND THE LEAD ITSELF. WITHOUT A DEFINITIVE REASON FOR THE LEAD NOISE THE PHYSICIAN DECIDE THAT BOTH THE LEAD AND DEVICE REQUIRED REPLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACE ON (B)(6) 2021. THE PATIENT REMAINED STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968010 ↗
• InjuryJun 30, 2020Incorrect Measurement; Incorrect Measurement

  DURING REMOTE MONITORING, THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED THE BATTERY VOLTAGE DROPPED MORE THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI AND SUSPECTED OVERESTIMATION OF BATTERY LONGEVITY BY THE PROGRAMMER AT THE PREVIOUS FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10214567 ↗
• MalfunctionApr 23, 2020Misconnection; Misconnection

  DURING A DEVICE EXCHANGE PROCEDURE, THE SUPERIOR VENA CAVA (SVC) CONNECTOR OF THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE DISCONNECTED FROM THE DEVICE HEADER. THE SET SCREW WAS STRIPPED AND KEPT ROTATING. THE SVC CONNECTION OF THE RV LEAD WAS CUT AND CAPPED. THE NEW DEVICE WAS IMPLANTED AND THE SVC PORTION WAS PLUGGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993788 ↗
• InjuryDec 19, 2019Data Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. SIX MONTHS AGO, THE BATTERY LONGEVITY WAS 2.4 YRS, DURING INTERROGATION ON (B)(6) 2019, THE LONGEVITY WAS LESS THAN 3 MONTHS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497112 ↗
• InjuryNov 12, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR INTERROGATION IN APRIL, THE DEVICE INDICATED A LONGEVITY ESTIMATE OF 1.4 YEARS LEFT OF BATTERY. IN SEPTEMBER, THE PATIENT RECEIVED A VIBRATORY ALERT FOR ELECTIVE REPLACEMENT INDICATOR (ERI). THE PHYSICIAN REPLACED THE DEVICE AND THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9312233 ↗
• InjuryOct 3, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION AND THE PATIENT EXPERIENCED INCREASED FATIGUE. PATIENT WAS SCHEDULED FOR REPLACEMENT PROCEDURE. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE FOLLOW UP VISIT.

  Patient problems: Fatigue

  MAUDE report 9154094 ↗
• InjuryAug 30, 2019Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT CAME INTO CLINIC AFTER REPORTEDLY BEING SHOCKED WHEN THE DEVICE WAS END OF SERVICE. IT WAS UNKNOWN IF THE SHOCK WAS APPROPRIATE OR NOT AS THE ELECTROGRAM WAS UNAVAILABLE DUE TO EXCESSIVE ELECTROGRAMS TAKING UP STORAGE. SOME VENTRICULAR TACHYCARDIA EPISODES THAT WERE VISIBLE WERE NOT APPROPRIATE. IT WAS DECIDED TO TURN THE DEVICE OFF AND NOT REPLACE IT DUE TO PATIENT SPECIFIC REASONS AND NOT DUE IN ANY WAY TO THE DEVICE. THERE WAS NO COMPLAINT THAT THIS WAS PRECIPITOUS DEPLETION. PATIENT STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8949821 ↗
• InjuryJul 9, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT WHILE THE DEVICE DID NOT ISSUE ANY ALERTS, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8773566 ↗
• MalfunctionJul 6, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE THE SUPRAVENTRICULAR CARDIAC LEAD SET SCREW WAS OBSERVED TO BE STRIPPED. MULTIPLE WRENCHES WERE USED IN ATTEMPT TO REMOVE THE SCREW BUT FAILED. THE LEAD WAS CAPPED ON (B)(6) 2019. THE DEVICE WAS EXPLANTED AND REPLACED. NO CLINICAL COMPLICATIONS OCCURRED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8765722 ↗
• InjuryJun 21, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8720966 ↗
• MalfunctionJun 18, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT PROCEDURE, THE SET SCREW COULD NOT BE RELEASED WELL. DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8710214 ↗
• InjuryMay 23, 2019Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN@HOME TRANSMISSION. UPON REVIEW, THE PATIENT RECEIVED AN INAPPROPRIATE HIGH VOLTAGE SHOCK DURING ATRIAL FIBRILLATION FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WENT BACK INTO SINUS RHYTHM AFTER THE SHOCK. THE PATIENT WAS STABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-06170.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8636617 ↗
• MalfunctionMay 14, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DID NOT CONNECT WITH RADIOFREQUENCY (RF) TELEMETRY. THE RF ANTENNA WAS UNPLUGGED AND THE DEVICE COULD BE INTERROGATED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8610273 ↗
• MalfunctionMay 5, 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 8580851 ↗
• MalfunctionMay 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING FOLLOW-UP, OVERSENSING DUE TO NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND REVEALED NO ANOMALIES. DURING THE NOISE EPISODES THE DEVICE BEGAN CHARGING BUT STOPPED AND DID NOT DELIVER INAPPROPRIATE HIGH VOLTAGE THERAPY. THE PHYSICIAN ALLEGED A MALFUNCTION ON THE DEVICE. THE DEVICE WAS THEN EXPLANTED AND REPLACED DUE TO NORMAL ERI AND THE RV LEAD WAS CAPPED AND REPLACED DURING THIS UNRELATED PROCEDURE. THE PATIENT WAS IN STABLE CONDITION. RELATED TO MANUFACTURER REPORT NUMBER: 2938836-2019-03264.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8568534 ↗
• DeathApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-05329. IT WAS REPORTED THE PATIENT DECEASED. 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 WAS UNKNOWN.

  Patient problems: Death

  MAUDE report 8505495 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATION ROOM. THE PULSE GENERATOR AND RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO INFECTION. NO FURTHER INFORMATION WAS AVAILABLE. THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 01/31/2018 UNDER AUTHORIZATION NUMBER E19974033 FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8461240 ↗
• MalfunctionMar 18, 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 8429784 ↗
• InjuryMar 14, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422457 ↗
• MalfunctionMar 11, 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 8408244 ↗
• DeathMar 5, 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.

  Patient problems: Death

  MAUDE report 8392651 ↗
• MalfunctionFeb 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 8379326 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2938836-2019-00414. PRIOR TO A DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), POCKET EROSION AND SIGNS OF INFECTION WERE OBSERVED. DURING THE PROCEDURE, THE SUTURE SLEEVE OF THE RIGHT VENTRICULAR (RV) LEAD HAD MIGRATED TO THE SURFACE. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Pocket Erosion; Skin Erosion

  MAUDE report 8264986 ↗