Viva™ CRT-P C6TR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00643169351905), received between Dec 9, 2016 and Jun 9, 2026 — classified as 1 death, 96 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (32 reports).

10 other recalls cover devices cleared under the same FDA submission (P010015); they may or may not involve this specific model.

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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAS BEEN "GIVING ME TROUBLE", THAT THEY WERE NOT "GETTING ENOUGH BEATS" AND THAT THEY EXPERIENCED SHORTNESS OF BREATH. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 25447942 ↗
• MalfunctionMar 6, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED PATIENT TO THE CLINIC. THE DEVICE AND MONITOR 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 21537398 ↗
• InjuryMar 3, 2025Incorrect Measurement; Incorrect Measurement

  FOLLOW UP WAS CONDUCTED AND IT WAS FURTHER REPORTED THAT THE CRT-P HAD NORMAL BATTERY DEPLETION WITH NO FLUCTUATIONS NOTED, THE PATIENT'S HIGH HEART RATE WAS NOT CONFIRMED, AND THE PATIENT'S MOST RECENT PROCEDURE WAS A BILATERAL BREAST LUMPECTOMY.

  Patient problems: Syncope/Fainting; Tachycardia

  MAUDE report 21510634 ↗
• InjuryNov 27, 2024Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT DURING A GENERATOR REPLACEMENT PROCEDURE, THE DEVICE FEATURE THAT MEASURES LEAD IMPEDANCES, CAUSED A POLARITY SWITCH AND LOSS OF CAPTURE WHEN THE DEVICE WAS REMOVED FROM THE POCKET. THE DEVICE WAS REPROGRAMMED AND CAPTURE WAS CONFIRMED. PACING SUPPORT WAS PROVIDED, VIA ANALYZER, WHILE THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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 20791924 ↗
• MalfunctionOct 30, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS FURTHER REPORTED THAT THE CRT-P WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569703 ↗
• MalfunctionMar 28, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN EXTERNAL CARDIAC MONITOR CAPTURED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PACING AT A LOWER RATE OF BETWEEN THIRTY TO FORTY BEATS PER MINUTE WHICH IS BELOW THE PROGRAMMED LOWER RATE SETTING. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18994381 ↗
• MalfunctionMar 18, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURERS ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923126 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY NINE YEARS FOLLOWING IMPLANT, THE PATIENT PRESENTED FOR A ROUTINE CHANGEOUT DUE TO THE DEVICE REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED WHEN THE PROCEDURE STATED THAT THERE WAS REDNESS AND A POCKET INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 18834020 ↗
• InjuryJan 13, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD PREMATURE BATTERY DEPLETION. THE CRT-P AND LV LEAD WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509557 ↗
• MalfunctionDec 21, 2023Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) CHANGE OUT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE ATRIAL TIP TO ATRIAL RING AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NOISE, LV TIP TO CAN ON ELECTROGRAMS (EGM), SO EXTERNAL NOISE SUSPECTED BUT NOT WAS NOT CONFIRMED.  THE CRT-P WAS EXPLANTED AND REPLACED.  THE RA 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 18379646 ↗
• MalfunctionDec 8, 2023Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATIONS DURING THE MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292132 ↗
• InjuryNov 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT A NURSE THOUGHT THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS DEFIBRILLATING THEM. IT WAS NOTED THAT THE CRT-P CANNOT PROVIDE HIGH VOLTAGE SHOCKS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE AND WAS EXHAUSTED. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue; Syncope/Fainting

  MAUDE report 18174548 ↗
• MalfunctionOct 20, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN AFTER THE EMERGENCY DEPARTMENT VISIT. THERE WERE NO DEVICE PACING ISSUES AND NO RE PROGRAMMING WAS DONE.

  Patient problems: Arrhythmia; Chest Pain

  MAUDE report 17980170 ↗
• MalfunctionSep 6, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS UNABLE TO BE INTERROGATED. THE CRT-P REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY FOUR YEARS PRIOR. IT WAS NOTED THAT END OF SERVICE (EOS) TYPICALLY OCCURS THREE MONTHS FOLLOWING ERI. IT WAS ALSO NOTED THAT THE DEVICE VOLTAGE WAS BELOW EOS VOLTAGE WHEN LAST CHECKED APPROXIMATELY ONE YEAR PRIOR. THE CRT-P REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE CRT-P WAS CONFIRMED TO BE A EOS APPROXIMATELY ONE YEAR PRIOR. THE PATIENT REFUSED A DEVICE CHANGE OUT PROCEDURE AND UNDERSTOOD THAT THE DEVICE WAS NO LONGER FUNCTIONING DUE TO IT BEING AT EOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695012 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY EIGHT YEARS POST CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT. IT WAS DISCOVERED THAT A SURGICAL SPONGE HAD BEEN LEFT IN THE POCKET. THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND SWELLING. THE CRT-P WAS REPORTEDLY PLACED BACK IN THE POCKET; HOWEVER, THE SYSTEM WAS REMOVED A FEW DAYS LATER AND A SINGLE CHAMBER PACEMAKER SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17625550 ↗
• MalfunctionJul 25, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT TELEMETRY WAS ABLE TO BE ESTABLISHED. A TRANSMISSION WAS SUCCESSFUL SINCE THE REPORTED EVENT DATE PER THE DATABASE. THE PATIENT LIVES IN A REMOTE AREA AND THE MONITOR WAS UNABLE TO RECEIVE WIFI SIGNAL. NO INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392828 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC MULTIPLE TIMES IN THE LAST TWELVE MONTHS WITH POCKET SWELLING. FLUID WAS ASPIRATED FROM THE POCKET AND LAB TESTING WAS NEGATIVE FOR INFECTION OR BACTERIA. THE PHYSICIAN ELECTED TO REMOVE THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEADS AND IMPLANT A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). CULTURES TAKEN WERE NEGATIVE FOR INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema

  MAUDE report 17295501 ↗
• MalfunctionMay 23, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT, PACING INHIBITION WAS OBSERVED. IT WAS DETERMINED THAT LOOSENING THE SETSCREW AND REMOVING THE RIGHT VENTRICULAR (RV) LEAD CAUSED OVERSENSING THAT RESULTED IN THE PACING INHIBITION. THE PHYSICIAN WAS ABLE TO CONNECT THE RV LEAD TO A NEW DEVICE AND PACING WAS RESUMED. THE DEVICE WAS EXPLANTED AND REPLACED AS PLANNED. 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 16985648 ↗
• MalfunctionDec 22, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS NOT READING THE IMPLANT. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED TO THE CLINIC. THE REMOTE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT REPORT THAT THE READER WAS NOT READING THE DEVICE WHEN ATTEMPTING TO SEND A MANUAL TRANSMISSION. THE PREVIOUS ATTEMPT TO SEND A MANUAL TRANSMISSION WAS SUCCESSFUL. THE DEVICE 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 16035249 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED DUE TO INFECTION AND THE LEADS COMING OUT OF THE SKIN. ANATOMICAL ISSUES PREVENTED SYSTEM REPLACEMENT ON THE PATIENT'S OPPOSITE SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 15705389 ↗
• MalfunctionOct 28, 2022Pacing Problem; Capturing Problem; Pacing Problem; Capturing Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN OFFICE NOTED THE DEVICE APPEARING NOT TO BE PACING AND CAPTURING WAS NOT CONFIRMED. THE PHYSICIAN OFFICE NOTED THAT THERE WAS FUSION WITH PREMATURE VENTRICULAR CONTRACTIONS (PVC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691598 ↗
• InjuryAug 25, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) RECORDED POLARITY SWITCHES DUE TO LOW IMPEDANCE ON THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS, AND NON-SUSTAINED VENTRICULAR TACHYCARDIA AND ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WITH POSSIBLE NOISE AND OVERSENSING DURING AN OPERATION INVOLVING CAUTERY. POLARITY WAS REPROGRAMMED AND THE CRT-P 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 15294674 ↗
• MalfunctionJul 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD, COMPLICATIONS WITH THE DEVICE WERE NOTED. THE CRT-D AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884765 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. ANTIBIOTIC TREATMENT WAS ADMINISTERED. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14799348 ↗
• MalfunctionJun 2, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED ONE EPISODE OF ELECTROMAGNETIC INTERFERENCE. THE DEVICE 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 14575944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. One submission often covers many models, so check the product and lot details in each record.

• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2412-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.