TRANSVENE®-CS/SVC 6937A-52 (UDI 00643169536029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169536029), received between Nov 19, 2018 and May 1, 2026 — classified as 16 injuries, 10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON A VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF) EPISODE. REPROGRAMMING WAS DONE, BUT THERE WAS FURTHER OVERSENSING ON THE RV LEAD, AND EVENTUALLY AN INAPPROPRIATE SHOCK. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25059804 ↗
• InjurySep 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 23052106 ↗
• InjuryJul 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED POST POCKET CLOSURE ON THE DAY OF IMPLANT. THE LEAD WAS REPOSITIONED AND 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 22408483 ↗
• MalfunctionMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE RIGHT VENTRICULAR (RV) LEAD. 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 22029128 ↗
• MalfunctionOct 7, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE DEVICE BATTERY LONGEVITY WAS LOWER THAN EXPECTED. A REVIEW OF THE DEVICE DATA BY QUALIFIED PERSONNEL DETERMINED THAT THE DEVICE HAD BEEN TONING FOR SEVERAL MONTHS DUE TO UNSUCCESSFUL REMOTE TRANSMISSION, WHICH WOULD ACCOUNT FOR VOLTAGE DIPS AND VARIATION IN PREDICTED LONGEVITY. IT WAS FURTHER REPORTED THAT THERE WAS UNDEFINED HIGH RIGHT VENTRICULAR (RV) DEFIBRILLATOR IMPEDANCE ON THE HIGH VOLTAGE LEAD. THE EPICARDIAL RIGHT ATRIAL (RA) AND RV PACING LEADS EXHIBITED HIGH CAPTURE THRESHOLDS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 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 20385726 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A POCKET INFECTION AND WOUND DEHISCENCE DUE TO HAVING A COMPETITOR TRANSVENOUS GENERATOR AND LEADS; THIS WAS DEEMED THE SOURCE OF INFECTION. THE COMPETITOR WAS EXPLANTED AND REPLACED WITH THE CURRENT ICD SYSTEM WHICH WAS STATED TO NOT BE CONSIDERED THE SOURCE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20058813 ↗
• MalfunctionJun 27, 2024High impedance; Over-Sensing; Impedance Problem; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND RV PACING IMPEDANCE VARIATION. IT WAS ALSO REPORTED THAT THE RV LEAD TRIGGERED ALERTS DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND HIGH OOR DEFIBRILLATION IMPEDANCE. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 19624566 ↗
• MalfunctionFeb 13, 2024High impedance; High impedance

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) HAD PREVIOUSLY TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). MORE RECENTLY, THERE WAS POSSIBLE UNDERSENSING OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN AT THE EMERGENCY ROOM. THERE WAS AN ALERT DUE TO HIGH RV DEFIBRILLATOR IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699819 ↗
• MalfunctionJan 22, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT AN IMPEDANCE ALERT TRIGGERED DUE TO HIGH/UNDEFINED RIGHT VENTRICULAR (RV) DEFIBRILLATOR COIL IMPEDANCE. A FRACTURE WAS SUSPECTED. 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 18553045 ↗
• 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 17459930 ↗
• InjuryJul 12, 2023Adverse 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 EXTRACTED DUE TO AN INFECTION. THE SYSTEM WAS REPLACED WITH AN IPG AND A PACING RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17308270 ↗
• MalfunctionJan 19, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH SENSING INTEGRITY COUNTER (SIC) VALUE. 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 16204885 ↗
• MalfunctionNov 2, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CURRENTLY BEING USED FOR SENSING FUNCTION WAS OBSERVED TO BE UNDERSENSING DURING SOME EPISODES. IT WAS FURTHER REPORTED THAT HIGH RV THRESHOLDS WERE ALSO OBSERVED, PRESUMABLY ON THE LONGER LENGTH OF THE 2 RV LEADS. BOTH RV 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 15716730 ↗
• InjuryOct 5, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNDERSENSING. 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 15542594 ↗
• InjuryJul 26, 2022Adverse 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 THE PATIENT DEVELOPING BACTEREMIA AND SEPSIS. DEVICE DETECTIONS AND THERAPIES WERE DISABLED PRIOR TO EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 15101578 ↗
• InjuryMay 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A "FAILURE" AND 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 14515767 ↗
• MalfunctionMay 7, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THERE WAS CROSS CHAMBER OVERSENSING AS THE RIGHT VENTRICULAR (RV) LEAD WAS SENSING THE P-WAVE. NO INTERVENTION WAS TAKEN 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 14317065 ↗
• MalfunctionMar 9, 2022High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO AUDIBLE ALERTS TRIGGERED BY THEIR RIGHT VENTRICULAR (RV) LEADS. INTERROGATION SHOWED THAT THE EPICARDIAL RV LEAD EXHIBITED HIGH UNDEFINED OUT OF RANGE (OOR) RV DEFIBRILLATION IMPEDANCE, AND THE ENDOCARDIAL RV LEAD EXHIBITED HIGH UNDEFINED OOR SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE PATIENT WAS ADMITTED FOR "BEING DRY" AND WAS ADMINISTERED FLUIDS. IT WAS NOTED THAT "IMPEDANCES CAME BACK DOWN OVERNIGHT" AFTER THE PATIENT RECEIVED FLUIDS. 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 13714190 ↗
• InjuryNov 19, 2021High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE LEADS WERE EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846834 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. THE STATUS OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12519818 ↗
• InjurySep 2, 2021Break; Positioning Problem; Break; Positioning Problem

  IT WAS FURTHER REPORTED THAT PAIN AT THE IMPLANT POCKET SITE PROMPTED THE LEAD'S EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12413775 ↗
• InjuryApr 9, 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11644943 ↗
• InjuryApr 9, 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11644821 ↗
• InjuryJul 16, 2019High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES ROSE SHARPLY TO HIGH LEVELS. A NEW TRANSVENOUS SYSTEM WAS IMPLANTED AND THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795576 ↗
• InjuryMar 20, 2019High impedance; Failure to Convert Rhythm; High impedance; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR IMPEDANCE OUT OF RANGE IN THE DEFIBRILLATOR COILS. IT WAS FOUND THAT THE SUPERIOR VENA CAVA (SVC) EPICARDIAL PATCH HAD LOW IMPEDANCE AND HAD BEEN SEEN TO HAVE HIGH IMPEDANCE. A CHEST X-RAY SHOWS THAT THE EPICARDIAL PATCH HAD MIGRATED. THE EPICARDIAL PATCH WAS CAPPED AND A NEW EPICARDIAL PATCH WAS IMPLANTED. IT WAS FURTHER REPORTED THAT A TRANSVENOUS LEAD WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED. THE TRANSVENOUS LEAD HAD HIGH IMPEDANCE AND FAILED DEFIBRILLATION THRESHOLD (DFT) TESTS. THE LEAD WAS REMOVED AND A SUBCUTANEOUS LEAD WAS ATTEMPTED TO BE IMPLANTED. WHILE ATTEMPTING TO IMPLANT THE SUBCUTANEOUS LEAD, THE PHYSICIAN NICKED THE RIGHT ATRIUM CAUSING BLEEDING. THE PHYSICIAN HAD TO PERFORM OPEN HEART SURGERY TO REPAIR THE WOUND. SINCE THE CHEST CAVITY WAS OPENED, THE PHYSICIAN DECIDED TO IMPLANT AN EPICARDIAL PATCH AFTER THE WOUND WAS TREATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8437799 ↗