VOLTA 1CR 65Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04035479143374), received between Jul 18, 2019 and Jul 13, 2021 — classified as 1 death, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2021Over-Sensing; Over-Sensing

  OVERSENSING AND LOSS OF CAPTURE WAS REPORTED APPROX. 62 MONTHS AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160428 ↗
• InjurySep 23, 2020Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SUBJECT LEAD WAS REMOVED DUE TO INAPPROPRIATE SHOCKS. ACCORDINGLY, THESE SHOCKS WERE A RESULT OF LEAD DISLODGEMENT CAUSED BY TWIDDLERS SYNDROME. NO PATIENT FILES ARE AVAILABLE IN RELATION TO THE REPORTED ISSUE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: Shock from Patient Lead(s); Twiddlers Syndrome

  MAUDE report 10576807 ↗
• MalfunctionJul 22, 2020Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  AT 1-WEEK FOLLOW-UP, RV LEAD THRESHOLD WAS NORMAL AT 0.50V @ 0.50MS. AT THE 3-MONTH VISIT, THRESHOLD HAD INCREASED TO 4.0V @ 0.50MS. THEN, AT THE 6-MONTH VISIT ON (B)(6) 2016, THERE WAS NO CAPTURE OF THE RV LEAD. ON (B)(6) 2016, PATIENT UNDERWENT RV LEAD REVISION DUE TO DISLODGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311864 ↗
• DeathJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: ON (B)(6) 2017, PATIENT PRESENTED 2 WEEKS STATUS-POST RIGHT TOE/FOOT RESECTION COMPLAINING OF RIGHT FOOT PAIN, ERYTHEMA AND SWELLING. FOOT CULTURE (B)(6) FOR (B)(6). TREATMENT PLAN PER INFECTIOUS DISEASE. ON (B)(6) 2017, PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH WORSENING SHORTNESS OF BREATH, LOWER EXTREMITY EDEMA AND ASCITES. BLOOD CULTURES (B)(6) FOR (B)(6) ON (B)(6) 2017, AND (B)(6) 2017. TREATED WITH INTRAVENOUS DAPTOMYCIN. RIGHT FOOT NOW CONSISTENT WITH OSTEOMYELITIS. ON (B)(6) 2017, DEVICE SITE WAS ERYTHEMOUS. DEVICE AND THREE LEADS WERE EXTRACTED ON (B)(6) 2017. TISSUE SHOWED EVIDENCE OF INFECTION (B)(6) FOR (B)(6). ON (B)(6) 2018, FOLLOWING SIX WEEKS OF OUTPATIENT DAPTOMYCIN, BLOOD CULTURE FROM (B)(6) 2018 WAS (B)(6) FOR (B)(6). SWITCHED TO INTRAVENOUS VANCOMYCIN. PATIENT NEVER FULLY RECOVERED FROM SYSTEMIC (B)(6) INFECTION AND EVENTUALLY PASSED AWAY.

  Patient problems: Death; Unspecified Infection

  MAUDE report 10311518 ↗
• InjuryJul 9, 2020Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  LIVA NOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: INAPPROPRIATE SHOCKS WERE REPORTED ON THIS LEAD. THE INTERROGATION REVEALED AN RV COIL IMPEDANCE OF 200 OHMS BEGINNING IN (B)(6) 2020. DEVICE THERAPY WAS TURNED OFF.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10251656 ↗
• MalfunctionMar 17, 2020Signal Artifact/Noise; Fracture; Ambient Noise Problem; Signal Artifact/Noise; Fracture; Ambient Noise Problem

  LIVANOVA PROVIDED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THERE IS NOISE ON THIS LEAD. DURING ROUTINE TESTING IT WAS FOUND THAT THE RV LEAD IS BROKEN. THE PATIENT DOES A LOT OF WEIGHT LIFTING AND THE PHYSICIAN THINKS THAT MAY HAVE CONTRIBUTED TO THE FRACTURE. ARTIFACTS WERE SEEN ON THE ELECTROGRAMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9838904 ↗
• MalfunctionDec 18, 2019Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS EXPLANTED DUE TO OVERSENSING AND NOISE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489143 ↗
• InjuryJul 18, 2019Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ON THE (B)(6), 54 MONTHS AFTER THE IMPLANTATION, IT WAS REPORTED THAT OVERSENSING WITH SHOCK DELIVERY OCCURRED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8803048 ↗