TRANSVENE®-CS/SVC 6937A-58 (UDI 00643169535985)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169535985), received between Feb 9, 2017 and Feb 19, 2026 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High impedance” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD FAILED DEFIBRILLATION THRESHOLD (DFT) TESTING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390379 ↗
• MalfunctionFeb 3, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THREE DAYS POST IMPLANT OF THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD, THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS JUMPED TO HIGH. IT WAS ALSO REPORTED THAT THERE WAS A LOW LEFT VENTRICULAR (LV) LEAD IMPEDANCE WARNING. THE RV LEAD, SVC LEAD AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249195 ↗
• MalfunctionJan 14, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073674 ↗
• MalfunctionDec 22, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO AN ABRUPT DROP IN DEFIBRILLATION IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866226 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET SITE. AT THE REQUEST OF THE PATIENT THE ICD SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT. IT WAS NOTED DURING THE EXPLANT PROCEDURE THAT THE STYLET WAS UNABLE TO ADVANCE ALL THE WAY THROUGH THE AZYGOUS COIL LEAD AND THE LEAD WAS UNABLE TO BE REMOVED. THE LEAD WAS CUT AND REMAINS IN THE PATIENT. THE RIGHT ATRIAL (RA) LEAD EXHIBITED EXPLANT DIFFICULTLY. THE RA AND RV LEADS WERE FULLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23761547 ↗
• InjurySep 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S INITIAL DEFIBRILLATION COIL LEAD HAD DISLODGED AND MIGRATED TO THE PLEURAL SPACE AND THE SECOND D EFIBRILLATION COIL LEAD HAD A HIGH VOLTAGE FRACTURE. THE MIGRATED LEAD WAS CAPPED AND THE FRACTURED LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052091 ↗
• InjurySep 4, 2025Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965616 ↗
• MalfunctionJul 9, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH UNDEFINED AND A SPIKE IN SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460146 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWENTY DAYS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION RIGHT VENTRICULAR (RV) LEAD IM PLANT, THE PATIENT EXPERIENCED AN ESCHERICHIA COLI POCKET INFECTION WITH DISCOMFORT, PURULENT DISCHARGE, REDNESS, AND SWELLING. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE DEFIBRILLATION RV LEAD WAS EXPLANTED, THE EXISTING PACE/SENSE RV LEAD AND RIGHT ATRIAL (RA) LEAD REMAIN IN USE, AND THE ICD WAS EXPLANTED AND REPLACED WITH AN IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Discomfort; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 21516753 ↗
• MalfunctionJan 13, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE SVC DEFIBRILLATION IMPEDANCE HAD INCREASED, AND ADDITIONAL ALERTS HAD TRIGGERED FOR DEFIBRILLATION LEAD IMPEDANCE ABOVE THE PROGRAMMED ALERT THRESHOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135950 ↗
• InjuryApr 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19057105 ↗
• MalfunctionNov 30, 2023Impedance Problem; Impedance Problem

  IT WAS ALSO REPORTED THAT THE PACE/SENSE VENTRICULAR LEAD IMPEDANCE ALSO HAD RECENT VARIABILITY NOTED ON LEAD TRENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240328 ↗
• InjuryJul 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND WAS PULLED BACK ABOVE THE SUPERIOR VENA CAVA (SVC). THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406803 ↗
• MalfunctionJan 27, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND MULTIPLE SHORT V-VS PER DAY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251956 ↗
• MalfunctionOct 24, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE, HOWEVER IT WAS QUESTIONED IF THE OBSERVED PRODUCT PERFORMANCE WAS A RESULT OF THE PATIENT'S UNDERLYING CONDITION AT THE TIME OR A TRUE LEAD PERFORMANCE ISSUE. IT WAS ALSO NOTED THAT THE LEAD WAS IMPLANTED BY SUTURING IT TO THE PATIENT'S EPICARDIUM RATHER THANIMPLANTING THE LEAD TRANS-VENOUSLY WHICH MAY ALSO CONTRIBUTE TO THE OBSERVED LEAD IMPEDANCES. REVIEW OF RIGHT ATRIAL (RA) LEAD SENSING PARAMETERS SHOWED SMALL MEASURED P-WAVES AS WELL AS AMBIENT NOISE ON THE ELECTROGRAMS (EGM) WHICH WAS SUSPECTED TO BE DUE TO DIGITIZATION OF THE SIGNAL. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660694 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO SYSTEMIC INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11215171 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR FEVER AND WAS FOUND TO HAVE STREP BOVIS BACTEREMIA AND SUSPECTED ENDOCARDITIS. THE PATIENT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND IT WAS FOUND TO BE GROWING OUT COLIFORM BACTERIA. ANTIBIOTIC TREATMENT WAS PROVIDED AND CULTURES WERE TAKEN. A REPLACEMENT SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Fever; Unspecified Infection

  MAUDE report 10566566 ↗
• MalfunctionJan 21, 2020High impedance; High impedance

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED DUE TO HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. THE TRANSVENE SVC LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613345 ↗
• MalfunctionJul 19, 2018High impedance

  JUST OVER FIVE MONTHS POST IMPLANT IT WAS REPORTED THAT THE DEFIB IMPEDANCE FOR THE RIGHT VENTRICULAR (RV) LEAD HAS INCREASED ABOVE THE PROGRAMMED ALERT THRESHOLD AND THEREFORE TRIGGERED A RV DEFIB IMPEDANCE OUT OF RANGE ALERT. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7702525 ↗
• InjuryFeb 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) LEAD DISLODGED INTO THE PATIENT'S INTERNAL JUGULAR VEIN. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256416 ↗
• InjuryFeb 9, 2017Device Dislodged or Dislocated; Impedance Problem; Device Dislodged or Dislocated; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PHONED IN TO REPORT THAT THEIR DEVICE HAD DISLODGED. FOLLOW-UP WITH THE PATIENT'S CLINIC REVEALED THAT THE PATIENT WAS SEEN ON (B)(6) AND THE PATIENT IS CURRENTLY AN IN-PATIENT AT THE HOSPITAL. IT WAS DISCOVERED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A RV LEAD IMPEDANCE WARNING. VIA X-RAY IT WAS DISCOVERED THE LEAD WAS WRAPPED AROUND THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS THE PATEINET HAD "TWIDDLED" THE DEVICE AND ROTATED IT WITHIN THE POCKET, THEREFORE DISLODGING THE RV LEAD. ALL TACHY THERAPIES WERE PROGRAMMED "OFF" AT THAT TIME. THE DEVICE AND LEAD CURRENTLY REMAIN IN USE AND THE PATIENT WILL CONTINUE TO BE MONITORED UNTIL THE PHYSICIAN DECIDE HOW TO PROCEED WITH THE PATIENT'S TREATMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 6320425 ↗