TRANSVENE®-CS/SVC 6937A-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169535992), received between Dec 9, 2016 and May 21, 2026 — classified as 1 death, 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Low impedance

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE DEFIBRILLATION LEAD SUPERIOR VENA CAVA (SVC) IMPEDANCE WAS MEASURED AS LOW WITH THE SVC PROGRAMMED ON. THE SVC VECTOR WAS PROGRAMMED OFF AND THE IMPEDANCE RETURNED TO ACCEPTABLE OHMS. THE 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 25249771 ↗
• DeathJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER SUFFERING A VENTRICULAR TACHYCARDIA (VT) ARREST ON THE DAY OF THE RIGHT VENTRICULAR (RV) LEAD IMPLANT PROCEDURE.

  Patient problems: Cardiac Arrest; Tachycardia

  MAUDE report 22136579 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION, AND SUCCESSFULLY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18559050 ↗
• InjuryFeb 27, 2023Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444211 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT OF THE PATIENT'S RIGHT-SIDED SYSTEM, THE PATIENT WAS FOUND TO HAVE SYMPTOMATIC RIGHT-SIDED CENTRAL VENOUS STENOSIS/OCCLUSION. THE PATIENT'S RIGHT-SIDED SYSTEM AND CORONARY SINUS (CS) RIGHT VENTRICULAR (RV) LEAD WERE REMOVED AND A NEW LEFT-SIDED SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16112261 ↗
• InjuryNov 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEAD WAS PLACED EPICARDIALLY BUT DISLODGED APPROXIMATELY TWO WEEKS POST IMPLANT, AND WAS THEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835481 ↗
• 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 15337556 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INSULATION AND PROXIMAL PART OF THE COIL WAS DAMAGED WHILE ATTEMPTING TO IMPLANT THE LEAD IN THE LATERAL BRANCH OF THE CORONARY SINUS. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526562 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED APPROXIMATELY SIX WEEKS AFTER IMPLANT DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12211484 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO EROSION AND SUSPECTED INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WILL RECEIVE A NEW SYSTEM AT A FUTURE DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10028149 ↗
• MalfunctionDec 26, 2019Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT T-WAVE OVERSENSING (TWOS). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXPERIENCED INTERMITTENT OVER AND UNDERSENSING AS NOTED ON RECORDED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) EPISODES. THE RV AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 9520195 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8921432 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE ICD SYSTEM WAS REPLACED SEVERAL WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8695514 ↗
• InjuryJun 5, 2019Adverse 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8671669 ↗
• InjuryDec 9, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL (HCP) THAT A LEAD REVISION WAS COMPLETED. THE HCP WAS UNABLE TO DETERMINE WHICH LEAD(S) WERE REVISED FROM THE OPERATIVE NOTES. THE HIGH VOLTAGE 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 6162616 ↗