Tendril MRI™ LPA1200M-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,801 adverse event reports that list this exact device (DI 05414734504638), received between Jun 12, 2018 and Sep 28, 2026 — classified as 61 deaths, 1,053 injuries, 687 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (587 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 1,801 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Capture

  It was reported that the patient presented to clinic for a follow-up. It was noted that the right ventricular (RV) lead exhibited an elevated pacing threshold, resulting in ventricular non-capture with a subsequent delayed intrinsic ventricular conducted response. No changes or interventions were reported. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915686 ↗
• InjurySep 28, 2026Over-Sensing

  It was reported that the patient presented to clinic for a follow up. It was reported that the right ventricular (RV) lead exhibited oversensing noise resulting in pacing inhibition. The RV 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 50910608 ↗
• MalfunctionSep 28, 2026Break; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910510 ↗
• InjurySep 23, 2026Over-Sensing

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, the right ventricular lead exhibited noise that was oversensed by the device and led to pacing inhibition. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863270 ↗
• InjurySep 14, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the right ventricular (RV) lead exhibited noise over-sensing which resulted in pacing inhibition. The RV lead was subsequently explanted and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748016 ↗
• InjurySep 9, 2026Over-Sensing

  It was reported that the patient presented to the hospital for a lead revision procedure. The right ventricular (RV) lead exhibited oversensed noise, resulting in pacing inhibition. Additionally, the right atrial (RA) lead exhibited oversensed noise, resulting in inappropriate automatic mode switch (AMS) episodes. Both the RV and RA leads were explanted and replaced. The patient was discharged with no reported adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684746 ↗
• MalfunctionSep 9, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Upon review of the transmission, it was noted that the right ventricular lead (RV) exhibited noise oversensing due to Electro-magnetic interference (EMI) resulting in pacing inhibition of approximately 1.5 seconds. No intervention was performed. The patient status was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683553 ↗
• MalfunctionSep 4, 2026Over-Sensing

  It was reported through a remote transmission that the patient's right ventricular (RV) lead was over-sensing noise. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50604284 ↗
• InjurySep 3, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596718 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with bacteremia, suspected to have originated either from a foot infection or a urinary tract infection (UTI). On (b)(6) 2026, the physician elected to explant the entire pacing system, including the pacemaker, right atrial (RA) lead, and right ventricular (RV) lead. The patient remained in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50589378 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient presented with an effusion noted on the right ventricular lead. The lead was explanted and replaced on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50576286 ↗
• MalfunctionAug 26, 2026Failure to Capture; Device Sensing Problem

  Patient problems: Insufficient Information

  MAUDE report 50465045 ↗
• MalfunctionAug 24, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed high ventricular rate (HVR) episodes due to noise on the pacemaker and right ventricular (RV) lead. The patient will be continued to be monitored. No intervention was reported and the patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50406385 ↗
• MalfunctionAug 24, 2026Signal Artifact/Noise

  It was noted that the right atrial (RA) lead exhibited noise oversensing led to pacing inhibition. The physician noted that the right ventricular (RV) lead had a known history of noise. To minimize oversensing, the RA sensitivity setting was adjusted, and the RV lead was programmed off, with the device switched to AAI mode. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399739 ↗
• MalfunctionAug 21, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed high ventricular rate (HVR) episodes due to noise on the right ventricular (RV) lead and noise over-sensing resulting inappropriate automated mode switch (AMS) episodes on the right atrial (RA) lead. Programming changes were recommended. No patient symptoms or intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361933 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise

  It was reported that the patient presented for a follow up in clinic. It was noted that the right ventricular lead exhibited noise. The lead noise was reproducible with isometric testing. No intervention was performed. The patient remained in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50338325 ↗
• InjuryAug 17, 2026Capturing Problem

  It was reported that the patient presented prior to a scheduled device exchange procedure. During the device interrogation, it was noted that the right ventricular (RV) lead exhibited high capture threshold. The RV 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 50287677 ↗
• MalfunctionAug 12, 2026Over-Sensing

  It was reported that the patient presented for a follow up in clinic. It was noted that the right ventricular lead exhibited noise over-sensing resulted in high ventricular rates and pacing inhibition. The noise was reproduced with arm maneuvers and pocket manipulation. No intervention was performed. The patient was in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218359 ↗
• MalfunctionAug 5, 2026Signal Artifact/Noise

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137180 ↗
• InjuryJul 30, 2026Low impedance

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, the right ventricle lead exhibited low pacing impedance. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50079874 ↗
• InjuryJun 28, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA (B)(6). UPON REVIEW OF THE TRANSMISSION, THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED NOISE. THE PATIENT WAS BROUGHT INTO THE CLINIC, AND THE RV LEAD WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647420 ↗
• MalfunctionJun 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTED IN NOISE REVERSION EPISODES. NO CHANGES OR INTERVENTION WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542161 ↗
• InjuryJun 17, 2026Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE. PROGRAMMING CHANGES WAS PERFORMED; HOWEVER, THE RV LEAD WAS SUBSEQUENTLY CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529835 ↗
• InjuryJun 15, 2026Over-Sensing; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE CLINIC VISIT AND STATED THAT THEY EXPERIENCED HOT FLASHES. UPON INTERROGATION, IT WAS FOUND THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTING IN PACING INHIBITION, AND EXTRACARDIAC STIMULATION. PROGRAMMING CHANGES WERE MADE, AND THE RV LEAD WAS CAPPED ON (B)(6) 2025, AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 25498230 ↗
• MalfunctionJun 15, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE ATRIAL CHANNEL OF THE PACEMAKER AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. THE DEVICE WAS REPORTED TO BE APPROPRIATELY CAPTURING. NO INTERVENTIONS OR CHANGES WERE PERFORMED, AND THE PATIENT WILL CONTINUE TO BE MONITORED REMOTELY. THE PATIENT REMAINED IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498222 ↗

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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• 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-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.
• 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