Syncra™ CRT-P C2TR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00613994753304), received between Dec 9, 2016 and Aug 28, 2026 — classified as 1 death, 38 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient developed a pocket infection with symptoms of discomfort, purulent discharge/pus, redness, and wound dehiscence. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted and later replaced with a leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 50497045 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A SKIN RASH THAT HAD BECOME QUITE SEVERE. THE PATIENT HAD SEEN A DERMATOLOGIST FOR YEARS FOR THE SKIN RASH THAT DEVELOPED SHORTLY AFTER ORIGINAL IMPLANT. THE RASH WAS INITIALLY THOUGHT TO BE ECZEMA. THE PATIENT ALSO STATED THAT AFTER THE MOST RECENT DEVICE CHANGE OUT, THE RASH HAS GOTTEN PROGRESSIVELY WORSE. THE DERMATOLOGIST PERFORMED A BIOPSY AND DETERMINED THE SKIN RASH WAS DUE TO THE PATIENT BEING ALLERGIC TO YEAST AND NOT ANYTHING "IN THEIR DEVICE". THE YEAST INFECTION WILL BE TREATED BY THE PHYSICIAN. THE CRT-P HAS BEEN EXPLANTED AND THE LEADS REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fungal Infection; Rash

  MAUDE report 19395005 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD INFECTION WHICH INFECTED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE AND LEADS. THE PACING SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18857570 ↗
• InjuryJan 26, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS FURTHER REPORTED, VIA FOLLOW UP, THAT THE CRT-P WAS LATER EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS DOWNGRADED FROM A CRT-P TO AN IMPLANTABLE PULSE GENERATOR (IPG). THE LV LEAD WAS CAPPED AND NOT REPLACED.

  Patient problems: Tachycardia

  MAUDE report 18589674 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE BEGAN PROTRUDING FROM AN OPEN WOUND CAUSED BY THEIR SPOUSE, WHO HAS DEMENTIA, STRIKING THEM WITH A SPRINKLER HEAD. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND WILL BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s)

  MAUDE report 15455845 ↗
• InjuryDec 13, 2021Adverse 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) WAS EXPLANTED AND REPLACED DUE TO INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12990136 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT A ROUTINE DEVICE CHANGE OUT, THE PHYSICIAN NOTICED PUS IN THE POCKET. CULTURES WERE OBTAINED. THE PHYSICIAN DECIDED TO MOVE FORWARD WITH THE DEVICE CHANGE OUT AS THE PATIENT HAD NO SIGNS OR SYMPTOMS OF AN INFECTION. TWO WEEKS LATER, THE CULTURES WERE POSITIVE FOR AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12542314 ↗
• InjurySep 28, 2021Adverse 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) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12541647 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS REMOVED AND THE LEADS WERE PARTIALLY REMOVED. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12488276 ↗
• MalfunctionAug 20, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN, DIZZINESS, LIGHTHEADEDNESS, AND A HEART RATE IN THE FORTY BEATS PER MINUTE RANGE PER AN ELECTROCARDIOGRAM. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PROGRAMMED TO PACE AT A LOWER RATE OF SIXTY BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain; Dizziness

  MAUDE report 12348652 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET SWELLING AND PAIN. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS SCHEDULED FOR EVALUATION AND REVISION. DURING THE REVISION PROCEDURE WHEN THE DEVICE WAS REMOVED FROM THE POCKET A LARGE LIPOMA CYST ON THE ROOF WAS NOTED. THE CYST WAS SURGICALLY REMOVED, AND ANTIBIOTIC TREATMENT ADMINISTERED TO THE WOUND. A NEW IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED WITH AN ANTIBACTERIAL ENVELOPE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cyst(s); Pain; Swelling/ Edema

  MAUDE report 11831701 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE PATIENT EXPERIENCING ENDOCARDITIS, THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 11797533 ↗
• InjuryApr 6, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SHOWED NO LEAD TRENDS AND NO BATTERY LONGEVITY ESTIMATOR. THE DEVICE HAD BEEN IMPLANTED ALMOST FOUR YEARS AGO. THE PARAMETERS SCREEN SHOWED THAT THE IMPLANT DETECT WAS STILL ON. THIS WAS TURNED OFF AND 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 11619139 ↗
• InjuryMar 26, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD PREMATURE BATTERY DEPLETION. THE DEVICE 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 11575181 ↗
• InjuryFeb 11, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR (LV) LEAD HAD A HIGH PACING THRESHOLD. THE CRT-P WAS EXPLANTED AND REPLACED AND THE LV 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 11314019 ↗
• MalfunctionNov 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD CONCERNS ABOUT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) LONGEVITY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809832 ↗
• InjuryOct 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION AND THE HIS BUNDLE LEAD HAD HIGH AND UNSTABLE THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 10713319 ↗
• InjuryAug 25, 2020Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THE DEVICE COULD NOT BE INTERROGATED. IT WAS ALSO REPORTED THAT THE PATIENT'S HEART RATE WAS IN THE THIRTIES AND THERE WAS NO PACING. SUBSEQUENTLY, THE CRT-P WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 10449093 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. BOTH DEVICE SYSTEMS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10389109 ↗
• InjuryJul 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302376 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND OVERSENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9971247 ↗
• MalfunctionDec 23, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS MALFUNCTIONING AS IT WAS PACING THE PATIENT'S HEART AT AN EXTREMELY HIGH RATE. IT WAS NOTED THAT THE DEVICE HAD BEEN TURNED OFF FOR THE PATIENT TO UNDERGO AN ECHOCARDIOGRAM AT WHICH POINT IT BEGAN TO EXHIBIT THE REPORTED BEHAVIOR. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 9510916 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SEPSIS INFECTION OF AN UNKNOWN SOURCE. BLOOD CULTURES TAKEN WERE POSITIVE FOR CANDIDA PARAPSILOSIS AND COAGULASE NEGATIVE STAPHYLOCOCCUS. THE DEVICE AND LEADS WERE EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9350804 ↗
• MalfunctionOct 16, 2019Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED NOTED REPROGRAMMING WAS DONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9200534 ↗
• InjurySep 6, 2019Adverse 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) AND LEADS WERE EXPLANTED DUE TO POCKET INFECTION. IT WAS NOTED THAT THE LEADS ERODED THROUGH SKIN AND WERE VISIBLE OUTSIDE BODY. CULTURES WERE TAKEN. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8971936 ↗

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-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-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-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-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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.