Tendril MRI™ LPA1200M-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,125 adverse event reports that list this exact device (DI 05414734504683), received between Jun 11, 2018 and Sep 29, 2026 — classified as 52 deaths, 696 injuries, 377 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (247 reports).

5 other recalls cover devices cleared under the same FDA submission (P140033); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,125 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented in clinic for generator changeout procedure on (b)(6) 2026. Upon interrogation, it was found that the right ventricular (RV) and right atrial (RA) leads exhibited noise over-sensing, and both over-sensing of electromagnetic interference causing inappropriate automatic mode switch and pacing inhibition were further noted on the RA lead. The pacemaker was alleged for noise over sensing. The pacemaker was explanted and replaced, but both leads remained implanted and active. Patient condition was stable the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927918 ↗
• InjurySep 24, 2026Signal Artifact/Noise

  It was reported that noise was observed on the right atrial (RA) lead. The RA lead was explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885676 ↗
• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809210 ↗
• InjurySep 14, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented in clinic for a follow-up. Device interrogation indicated that the right atrial (RA) lead exhibited noise oversensing resulted in inappropriate mode switch. The RA lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749549 ↗
• MalfunctionSep 5, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50624271 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the right ventricular (RV) lead exhibited noise. During its extraction, a right atrial perforation occurred and resulted in cardiac tamponade, though it remains unknown which lead actually caused the tamponade. Both the RV and RA leads were extracted. The patient was in stable condition.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 50533154 ↗
• InjuryAug 31, 2026Signal Artifact/Noise

  It was reported that the right ventricular (RV) lead exhibited noise. During its extraction, a right atrial perforation occurred and resulted in cardiac tamponade, though it remains unknown which lead actually caused the tamponade. Both the RV and RA leads were extracted. The patient was in stable condition.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 50533151 ↗
• InjuryAug 27, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented to the clinic. Upon device interrogation, the atrial lead demonstrated noise oversensing, which resulted in inappropriate Auto Mode Switch (AMS). The atrial lead was capped and replaced on (b)(6) 2026. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50466422 ↗
• MalfunctionAug 27, 2026Over-Sensing; Pacing Problem

  It was reported through a remote transmission that the patient's right atrial (RA) lead was over-sensing noise resulted in inappropriate mode switch episodes. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465743 ↗
• MalfunctionAug 19, 2026Under-Sensing

  It was reported through a remote transmission that the patient's right atrial (RA) lead exhibited under-sensing. The patient had no adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50313700 ↗
• DeathAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to an unknown reason. No further information was provided.

  Patient problems: Insufficient Information

  MAUDE report 50312315 ↗
• MalfunctionAug 17, 2026Over-Sensing; Pacing Problem

  It was reported that the patient was monitored via Merlin.net. Review of the transmissions indicated that the right atrial lead exhibited noise. The noise intermittently resulted in oversensing and inappropriate mode-switch episodes. Programming changes were made to address the issue. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269414 ↗
• InjuryAug 11, 2026Insufficient Device Problem Information

  It was reported that the Right Atrial (RA) lead was capped due to an unknown issue on (b)(6) 2025. The patient condition was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214306 ↗
• MalfunctionAug 7, 2026Over-Sensing; Pacing Problem; Device Dislodged or Dislocated

  It was reported that a review of electrograms (EGMs) noted a possible dislodgement of the right atrial (RA) lead, sensing the right ventricle (RV) signal, resulting in an inappropriate automatic mode switch (AMS). Programming changes were made. The patient is not dependent and was asymptomatic.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50182950 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was presented to the hospital with infection. The pacemaker, right ventricular (RV) and right atrial (RA) leads were explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50151608 ↗
• InjuryAug 4, 2026High impedance

  It was reported that the patient presented via Merlin.net transmission on 05 August 2025 which revealed high pacing impedance on the right atrial (RA) lead. Subsequently, during a scheduled pulse generator replacement procedure, the RA lead was capped and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125409 ↗
• InjuryJun 17, 2026Failure to Capture; Fracture; High impedance; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH VERY HIGH RIGHT ATRIAL LEAD PACING IMPEDANCE. THE LEAD WAS ALSO NOT SENSING OR CAPTURING. CONDUCTOR FRACTURE WAS VISUALIZED WITH CHEST X-RAY. THE PRODUCT WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533776 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED DUE TO AN INFECTION. THE PATIENT'S CONDITION WAS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25521719 ↗
• MalfunctionJun 15, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A ROUTINE PACEMAKER GENERATOR REPLACEMENT. DURING THE PROCEDURE, THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS FOLLOWING DISCONNECTION FROM THE PACEMAKER. THERE WAS NO PRIOR HISTORY OF ELEVATED IMPEDANCE BEFORE THE GENERATOR CHANGE, WITH PREVIOUSLY NORMAL MEASUREMENTS REPORTED. DIAGNOSTIC IMAGING OF THE LEAD REVEALED NO EVIDENCE OF VISUAL FRACTURE. THE RA LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513540 ↗
• InjuryJun 3, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374975 ↗
• InjuryJun 3, 2026Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND LOW PACING IMPEDANCE. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374323 ↗
• InjuryMay 18, 2026Failure to Capture; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON DEVICE INTERROGATION, THE ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND LOSS OF SENSING. THE ATRIAL LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211873 ↗
• DeathMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DECEASED DUE TO DEMENTIA-RELATED CONSEQUENCES AND ARRHYTHMIA. THERE WERE NO NOTED ALLEGATIONS THAT THE ARRHYTHMIA WAS CAUSED BY AN ABBOTT PRODUCT OR ABBOTT RELATED PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 25165501 ↗
• MalfunctionMay 13, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS MONITORED VIA MERLIN.NET. THE TRANSMISSIONS SHOWED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25157153 ↗
• DeathMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25104525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140033. One submission often covers many models, so check the product and lot details in each record.

• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1531-2021 · Mar 15, 2021 · Open, Classified
  ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycar
• Z-1530-2021 · Mar 15, 2021 · Open, Classified
  ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.