TRANSVENE®-CS/SVC 6937A-35 (UDI 00643169536012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169536012), received between Jul 3, 2017 and Jul 29, 2026 — classified as 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “High impedance” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Fracture; High impedance; Impedance Problem

  It was reported that there was a spike to undefined high Right Ventricular (RV) Defibrillator coil impedance. A lead fracture was co nfirmed. The RV 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 50074225 ↗
• InjuryNov 12, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538009 ↗
• MalfunctionOct 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BY A PATIENT REPRESENTATIVE, THAT THE PATIENT IS HEARING PATIENT ALERT TONES, AGAIN.  THE PATIENT REPRESENTATIVE INDICATED THEY WERE IN CLINIC LAST WEEK AND APPARENTLY HAD THE PATIENT ALERT TONE CLEARED AND, THEY WERE TOLD EVERYTHING LOOKS GOOD WITH REGARDS TO THE PATIENT'S HEART CONDITION.  IN ADDITION, THE PATIENT REPRESENTATIVE NOTED THEY TRIED TO EXPLAIN THE REASON FOR THE TONE AND IT WAS NOT ENTIRELY CLEAR AND A BIT TECHNICAL FOR UNDERSTANDING AND NOTED THAT WAS RELAYED ABOUT THE PATIENT ALERT TONE HAD SOMETHING TO DO WITH TOO MUCH ENERGY PASSING THROUGH THE LEADS.  THE PATIENT REPRESENTATIVE WAS REFERRED TO THE PHYSICIAN.  THE RIGHT VENTRICULAR (RV) LEAD, EPICARDIAL RIGHT ATRIAL (RA) LEAD, EPICARDIAL RV LEAD AND EPICARDIAL LEFT VENTRICULAR (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 23343339 ↗
• MalfunctionOct 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BY A PATIENT REPRESENTATIVE, THAT THE PATIENT IS HEARING PATIENT ALERT TONES, AGAIN. THE PATIENT REPRESENTATIVE INDICATED THEY WERE IN CLINIC LAST WEEK AND APPARENTLY HAD THE PATIENT ALERT TONE CLEARED AND, THEY WERE TOLD EVERYTHING LOOKS GOOD WITH REGARDS TO THE PATIENT'S HEART CONDITION. IN ADDITION, THE PATIENT REPRESENTATIVE NOTED THEY TRIED TO EXPLAIN THE REASON FOR THE TONE AND IT WAS NOT ENTIRELY CLEAR AND A BIT TECHNICAL FOR UNDERSTANDING AND NOTED THAT WAS RELAYED ABOUT THE PATIENT ALERT TONE HAD SOMETHING TO DO WITH TOO MUCH ENERGY PASSING THROUGH THE LEADS. THE PATIENT REPRESENTATIVE WAS REFERRED TO THE PHYSICIAN. THE RIGHT VENTRICULAR (RV) LEAD, EPICARDIAL RIGHT ATRIAL (RA) LEAD, EPICARDIAL RV LEAD AND EPICARDIAL LEFT VENTRICULAR (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 23343309 ↗
• MalfunctionAug 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACING LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE. IN THE YEARS FOLLOWING, THE LEAD TRIGGERED TWO LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC) VALUE. THE DEFIBRILLATION RV LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH IMPEDANCE. ABOUT FIVE YEARS LATER, THE LEAD ALERTED FOR HIGH IMPEDANCE. ADDITIONALLY, THE DEFIBRILLATION SUPERIOR VENA CAVA (SVC) LEAD TRIGGERED AN ALERT FOR HIGH IMPEDANCE. ALL 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 22903683 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL HAD MOVED. THE PATIENT EXPERIENCED PNEUMOTHORAX. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pneumothorax

  MAUDE report 19620367 ↗
• InjuryMay 3, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD WARNING ON THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) DEFIBRILLATOR COILS. THE HIGH VOLTAGE IMPEDANCE TREND HAD BEEN RISING, AND NOW TRENDING TO UNDEFINED HIGH LEVELS. THE 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 19240051 ↗
• InjuryMay 3, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD WARNING ON THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) DEFIBRILLATOR COILS. THE HIGH VOLTAGE IMPEDANCE TREND HAD BEEN RISING, AND NOW TRENDING TO UNDEFINED HIGH LEVELS. THE 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 19240017 ↗
• InjuryApr 22, 2024High impedance; High impedance

  IT WAS FURTHER REPORTED THAT THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160175 ↗
• InjuryApr 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE SUPERIOR VENA CAVA (SVC) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH DEFIBRILLATION IMPEDANCE.  THE LEADS 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 19159934 ↗
• InjuryFeb 7, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD EXHIBITED RISING SVC DEFIBRILLATION IMPEDANCE WHICH BECAME HIGH AND TRIGGERED AN ALERT, AND REVIEW OF AN INTERROGATION SHOWED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD ALSO TRIGGERED AND ALERT FOR OUT OF RANGE (OOR) RV DEFIBRILLATION IMPEDANCE. THE SVC DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED, AND THE RV DEFIBRILLATION 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 18660745 ↗
• InjuryOct 30, 2023Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE HIGH VOLTAGE DEFIBRILLATION COIL LEAD EXHIBITED INTERMITTENT HIGH/UNDEFINED DEFIBRILLATION COIL IMPEDANCE MEASUREMENTS. ADDITIONALLY, DUE TO A CONFIRMED HIGH VOLTAGE CONDUCTOR FRACTURE AND VISUAL DEFORMITY NOTED ON THE LEAD, THE TIP-TO-COIL PACING IMPEDANCE WAS DISPLAYING PACING IMPEDANCES FROM APPROXIMATELY 450 OHMS TO GREATER THAN 4000 OHMS WHEN LEAD STRESSED JUST PROXIMAL TO DF-1 PIN. THERE WAS AN ACUTE HINGE POINT IN THE POCKET WHERE THE LEAD EXITED THE DEVICE HEADER. THE PHYSICIAN WAS ABLE TO SEE THE CONDUCTOR DISRUPTION THROUGH THE LEAD INSULATION. 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 18032605 ↗
• InjurySep 27, 2023Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. SUBSEQUENTLY, THE PATIENT RECEIVED INAPPROPRIATE SHOCKS THAT DID NOT TERMINATE THE ARRYTHMIA. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Shock from Patient Lead(s)

  MAUDE report 17825314 ↗
• InjuryAug 4, 2023High impedance; High impedance

  IT WAS REPORTED, THAT THERE WAS AN ALERT. FOR HIGH/UNDEFINED RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. HIGH/UNDEFINED RV DEFIBRILLATION COIL IMPEDANCE. AND WHEN THE SVC COIL WAS PROGRAMMED OFF, THE RV PACING LEAD HAD HIGH/UNDEFINED PACING IMPEDANCE. IT IS TO BE NOTED, THAT THE SVC COIL, RV COIL, AND RV PACING LEAD ARE THREE SEPARATE LEADS. DETECTIONS WERE PROGRAMMED OFF. AND 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 17459967 ↗
• MalfunctionJan 6, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS FURTHER NOTED THAT THERE WAS T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE (VS) ON THE DAY OF IMPLANT. 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 16112373 ↗
• MalfunctionSep 1, 2022Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS WERE EXHIBITING A GRADUAL INCREASE IN DEFIBRILLATION COIL IMPEDANCES (RV AND SUPERIOR VENA CAVA [SVC]). THE 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 15337538 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVE, AND THE PATIENT TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12923514 ↗
• MalfunctionMar 29, 2020Signal Artifact/Noise; Over-Sensing; Low impedance; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; Low impedance; High Capture Threshold

  IT WAS FURTHER REPORTED THAT AN ALERT WAS TRIGGERED FOR LOW PACING IMPEDANCE.

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

  MAUDE report 9896134 ↗
• MalfunctionJul 3, 2017Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THERE WAS UNDER AND OVER-SENSING OF THE R WAVES AND A TREND OF HIGHER PACING THRESHOLDS, THE RIGHT VENTRICULAR DEFIBRILLATOR LEAD DISPLAYED A TREND OF LOWER IMPEDANCE AND THERE WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND THE SENSING INTEGRITY COUNTER WAS NOTED. THE LEADS REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6684460 ↗