TRANSVENE-CS/SVCRecalls & reported problems across all models
Medtronic, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 106
- Deaths reported
- 1
- Injuries reported
- 67
- Recalls
- 0
We found 7 models of TRANSVENE-CS/SVC by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Jul 29, 2026 — classified as 1 death, 67 injuries, 38 malfunctions.
The most frequently reported specific device problem is “High impedance” (38 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TRANSVENE-CS/SVC problems
Device problems
- High impedance38
- Adverse Event Without Identified Device or Use Problem25
- Impedance Problem25
- Over-Sensing15
- Fracture9
- Device Dislodged or Dislocated8
- High Capture Threshold5
- Appropriate Device Problem Term/Code Not Available4
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Unspecified Infection18
- No Known Impact Or Consequence To Patient17
- Shock from Patient Lead(s)3
- Cardiac Arrest2
- Pain2
- Arrhythmia1
- Bacterial Infection1
TRANSVENE-CS/SVC models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRANSVENE®-CS/SVC 6937A-52permanent pacemaker Electrode26 reports
- TRANSVENE®-CS/SVC 6937A-58permanent pacemaker Electrode21 reports
- TRANSVENE®-CS/SVC 6937A-35Permanent defibrillator electrodes19 reports
- TRANSVENE®-CS/SVC 6937A-65permanent pacemaker Electrode1 death15 reports
- Transvene®-CS/SVC 6937A-35Permanent defibrillator electrodes14 reports
- Transvene®-CS/SVC 6937A-58permanent pacemaker Electrode6 reports
- Transvene®-CS/SVC 6937A-52permanent pacemaker Electrode5 reports
Recent TRANSVENE-CS/SVC adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionMay 21, 2026Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT SIC COUNTERS IN SOME OF THE STORED EPISODES WERE INCREMENTING QRS DOUBLE COUNTING. 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 25247948 ↗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 ↗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 ↗InjuryNov 18, 2025High impedance; Impedance Problem; High impedance; Impedance Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEAD EXHIBITED AN ABRUPT INCREASE IN IMPEDANCE. THE RV DEFIBRILLATION COIL LEAD EXHIBITED VARIABLE IMPEDANCE WITH A HIGH UNDEFINED MEASUREMENT NOTED. 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 23580030 ↗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 ↗MalfunctionNov 7, 2025High impedance; High impedance
IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL LEAD TRIGGERED ALERTS FOR HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCES, AND THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD TRIGGERED ALERTS FOR HIGH RV COIL AND PACING IMPEDANCE OOR AND ABOVE THE PROGRAMMED ALERT THRESHOLD, RESPECTIVELY. 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 23497433 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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