Plexa ProMRI S 60 402265Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 04035479140014), received between Oct 28, 2020 and Sep 15, 2026 — classified as 1 death, 108 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (40 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, 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 198 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Fracture; High impedance

  RV lead was capped due to impedance >3000 ohms, suspected lead fracture. No adverse patient events were reported. Should additional information be received this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778909 ↗
• InjurySep 9, 2026Fracture; High impedance; High Capture Threshold

  This lead was explanted due to RV pacing impedance had tripled from 625 to almost 1500 since early (b)(6) 2026. Pacing threshold increased same period, possibly due to RV lead fracture. Should additional information become available, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692198 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  System was explanted due to Vegetation noted in Echocardiogram of RV lead. Should additional information be received, this file will be updated.

  Patient problems: Unspecified Infection

  MAUDE report 50590287 ↗
• InjuryAug 26, 2026High impedance; High Capture Threshold

  This lead was capped due to impedance and threshold had increased over the past several months. No adverse patient events were reported. Should additional information be received, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457033 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  System was explanted due to infection. Should additional information be received, this file will be updated.

  Patient problems: Unspecified Infection

  MAUDE report 50230237 ↗
• InjuryJun 9, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  NOISE ON VARIOUS RECORDINGS RV LEAD AND FARFIELD SIGNAL LEADING TO VF DETECTIONS. ONE SHOCK WAS DELIVERED BUT THIS RECORDING WAS NOT TRANSMITTED TO HOME MONITORING AND 2 SHOCKS ABORTED. NURSE REPORTED THAT THESE EVENTS CORRELATED WITH 2 PROCEDURES ON (B)(6) 2026 AND (B)(6) 2026. ADVISED BRINGING PATIENT IN FOR FOLLOW UP AS THRESHOLD HAS RISEN SLIGHTLY AND TO VIEW VF RECORDING WITH SHOCK TO DETERMINE IF ARRYTHMIA OR NOISE. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25451144 ↗
• InjuryJun 1, 2026Fracture; Ambient Noise Problem

  RV LEAD WAS EXPLANTED DUE TO FRACTURE RESULTING IN NOISE. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349019 ↗
• InjuryMay 27, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem

  THIS LEAD WAS CAPPED DUE TO IMPEDANCE OUT OF RANGE AND NOISE WHICH LED TO INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25309947 ↗
• InjuryApr 8, 2026High impedance; Device Sensing Problem; High Capture Threshold

  LEAD WAS EXPLANTED DUE TO TRENDING ELEVATED PACING IMPEDANCE, HIGH CAPTURE THRESHOLD, LOW SENSING. NO OTHER ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821939 ↗
• InjuryMar 11, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  THIS RV LEAD WAS CAPPED DUE TO INAPPROPRIATE SHOCKS CAUSED BY NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24573339 ↗
• InjuryMar 2, 2026Failure to Capture

  THIS LEAD WAS EXPLANTED DUE TO LOC. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482630 ↗
• DeathFeb 18, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  PATIENT HAD RV LEAD NOISE THAT LEAD TO 3 INAPPROPRIATE SHOCK DELIVERIES ON (B)(6) 2026. THE PATIENT WAS SEEN IN OFFICE AND ICD THERAPY WAS DISABLED. THEY REMAINED IN THE HOSPITAL FOR A SCHEDULED LEAD REVISION WHICH OCCURRED TODAY (B)(6) 2026. DURING THE LASER SHEATH EXTRACTION THE SVC WAS INADVERTENTLY TORN RESULTING IN THE PATIENT EXPIRING. THERE IS NO COMPLAINT REGARDING THE DEVICE CONTRIBUTING TO THE EXPIRATION OF THE PATIENT. THE LEAD EXTRACTION WAS NOT COMPLETED, AND THERE IS NO PRODUCT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Cardiac Tamponade; Shock from Patient Lead(s)

  MAUDE report 24377054 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 24371916 ↗
• MalfunctionFeb 3, 2026Over-Sensing

  THIS LEAD SHOWS INTERMITTENT OVERSENSING. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251576 ↗
• InjuryFeb 2, 2026Impedance Problem

  LEAD WAS EXPLANTED DUE TO SHOCK IMPEDANCE OUT OF RANGE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232796 ↗
• MalfunctionJan 19, 2026Over-Sensing

  REPORTED INTERMITTENT OVERSENSING ON THE RV CHANNEL IN RECORDINGS TRANSMITTED TO HOME MONITORING. INCREASING THE GAIN REVEALS MULTIPLE ADDITIONAL DEFLECTIONS ON THE BASELINE, HOWEVER PATIENT ALSO HAS AN LVAD AND IT WAS UNCLEAR WHETHER THERE IS A LEAD INTEGRITY CONCERN OR EMI FROM THE LVAD IS INTERMITTENTLY BEING SENSED. FULL LEAD EVALUATION WAS RECOMMENDED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108624 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871806 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Cardiogenic Shock; Unspecified Infection

  MAUDE report 23821963 ↗
• MalfunctionDec 9, 2025High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO CHRONICALLY HIGH RV PACING THRESHOLD. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760947 ↗
• InjuryNov 10, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  PATIENT RECEIVED SHOCK FOR WHAT IS BELIEVED TO BE INAPPROPRIATE DETECTION. PATIENT WILL BE CONTACTED TO DISCUSS WHAT THEY WERE DOING AT THE TIME AND STEPS FOR FURTHER EVALUATION. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23509869 ↗
• MalfunctionSep 17, 2025Failure to Capture; Low impedance; Failure to Capture; Low impedance

  THIS LEAD WAS EXPLANTED DUE TO PACING IMPEDANCE <200 OHMS AND FAILURE TO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078304 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22965756 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION AT POCKET SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22921298 ↗
• MalfunctionAug 11, 2025Ambient Noise Problem; Ambient Noise Problem

  NOISE SEEN ON THE FAR-FIELD CHANNEL IN A SLOW NST RECORDING TRANSMITTED TO HOME MONITORING. SHOCK IMPEDANCE APPEARS STABLE THOUGH HMSC TRANSMISSION HAS BEEN INTERMITTENT. POSTURAL TESTING AND ISOMETRICS IN OFFICE WERE RECOMMENDED TO FURTHER EVALUATE THE LEAD. LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772893 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22666745 ↗