Current® 2107-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734502207), received between Nov 28, 2018 and Mar 13, 2023 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Failure to Interrogate” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2023 FOR A FOLLOW-UP. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS DISCOVERED TO BE IN BACKUP MODE AND THERE WAS INAPPROPRIATE SHOCK WHICH RESULTED IN VENTRICULAR TACHYCARDIA IN (B)(6) 2021. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 16535061 ↗
• InjuryDec 1, 2019Failure to Interrogate; Failure to Interrogate

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-16805. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT (ED) WITH NEAR SYNCOPE AND DYSPNEA. A MERLIN TRANSMISSION WAS ATTEMPTED WITHOUT SUCCESS. THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PATIENT STATED BEING NON-COMPLIANT FOR ROUTINE DEVICE FOLLOW-UPS AND NOTED THE DEVICE VIBRATING APPROXIMATELY TWO YEARS PRIOR TO THIS (B)(6) VISIT. THE PHYSICIAN ASSUMED THIS VIBRATORY ALERT WAS FOR ERI. DURING THE GENERATOR CHANGE-OUT ON A DEVICE SUSPECTED TO BE AT EOS, EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE RIATA LEAD VIA X-RAY. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND REMAINED STABLE POST PROCEDURE.

  Patient problems: Dyspnea; Syncope

  MAUDE report 9392667 ↗
• DeathSep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-12685, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-12687.

  Patient problems: Death

  MAUDE report 8961821 ↗
• InjuryMay 13, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8606326 ↗
• InjuryNov 28, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. NO COMMUNICATION COULD BE ESTABLISHED. IT WAS NOTED THAT PATIENT HAS FREQUENT VENTRICULAR TACHYCARDIA WITH MULTIPLE DISCHARGE THERAPY RESULTING IN BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110945 ↗