Plexa ProMRI S DX 65/17Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
All models of Plexa ProMRI (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Plexa ProMRI defibrillator electrode is an implanted electrode. It has 197 adverse event reports, with no deaths, 89 injuries and 108 malfunctions. Many describe infections, leads moving out of place and electrical noise on recordings, and some led to the system being removed. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 197
- Deaths reported
- 0
- Injuries reported
- 90
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 04035479158798), received between Jun 17, 2019 and Sep 24, 2026 — classified as 90 injuries, 107 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem71
- Device Dislodged or Dislocated40
- Ambient Noise Problem37
- Device Sensing Problem13
- High Capture Threshold13
- High impedance13
- Inappropriate/Inadequate Shock/Stimulation10
- Fracture9
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- Unspecified Infection61
- Shock from Patient Lead(s)10
- No Known Impact Or Consequence To Patient7
- Twiddlers Syndrome6
- Drug Resistant Bacterial Infection2
- Perforation2
- Pocket Erosion2
Recent adverse event reports
The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Impedance Problem
This lead was explanted due to unstable pacing impedance. 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 50886246 ↗InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This RV lead was explanted due to noise resulting in multiple inappropriate shocks. Should additional information be received, this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50783490 ↗InjuryAug 26, 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 50456383 ↗MalfunctionAug 3, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114609 ↗MalfunctionJul 31, 2026Ambient Noise Problem
Noise marked on atrial recordings and seen on atrial intracardiac, leading to atrial burden that may not be accurate of true arrythmia. This has been present since a month after implant. Recommended full follow up with isometrics to rule out lead integrity concerns. Home Monitoring values appear normal. Lead remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094124 ↗InjuryMay 14, 2026Ambient Noise Problem
NOISE WAS SEEN ON THIS LEAD. SHOCKING PORTION OF LEAD WAS CAPPED; PACE/SENSE REMAINS ACTIVE. 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 25175229 ↗InjuryApr 27, 2026Fracture
LEAD WAS EXTRACTED DUE TO 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 25010283 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO MRSA/STAPH INFECTION/BACTEREMIA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia; Drug Resistant Bacterial Infection
MAUDE report 25009092 ↗MalfunctionApr 9, 2026Ambient Noise Problem
THIS RV LEAD HAS A MONITORING ALERT FOR NOISE. NO ADVERSE PATIENT EVENTS WERE REPORTED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830439 ↗InjuryMar 23, 2026High impedance; High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO PACING IMPEDANCE >3000 OHMS AND ELEVATED THRESHOLD. 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 24661916 ↗InjuryMar 16, 2026High impedance; High Capture Threshold
LEAD WAS STABLE UNTIL RECENT UPGRADE FROM VR-T DX TO CRT-DX ON (B)(6) 2025. GRADUAL INCREASE IN RV PACING IMPEDANCE AND RV THRESHOLD WERE NOTED ON HOME MONITORING AND IN-CLINIC DEVICE CHECKS. THE LEAD WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604213 ↗InjuryFeb 3, 2026Impedance Problem
THIS LEAD WAS EXPLANTED DUE TO SHOCK IMPEDANCE OUT OF RANGE. 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 24249121 ↗InjuryFeb 2, 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 24232853 ↗InjuryJan 26, 2026Fracture
LEAD WAS EXPLANTED DUE TO FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185314 ↗InjuryJan 21, 2026Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE. 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 24132598 ↗InjuryJan 20, 2026Adverse 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 24115169 ↗InjuryJan 14, 2026Adverse 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 24072850 ↗InjuryJan 8, 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 24014847 ↗MalfunctionJan 8, 2026Fracture
THIS LEAD WAS EXPLANTED DUE TO FRACTURE. 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 24002595 ↗MalfunctionJan 5, 2026Impedance Problem
THIS LEAD WAS CAPPED DUE TO IMPEDANCES ISSUES. 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 23956600 ↗MalfunctionNov 25, 2025Over-Sensing; Over-Sensing
THIS LEAD SHOWS OVERSENSING AND 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 23652542 ↗MalfunctionNov 3, 2025Ambient Noise Problem; Ambient Noise Problem
NOISE WAS REPORTED BUT COULD NOT BE REPRODUCED WITH MYOPOTENTIAL. ALL LEAD TESTING IS STABLE. LEAD CURRENTLY REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23451179 ↗MalfunctionOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309998 ↗MalfunctionSep 8, 2025Impedance Problem; Unstable Capture Threshold; Impedance Problem; Unstable Capture Threshold
LEAD WAS EXPLANTED DUE TO RISING PACING IMPEDANCE AND THRESHOLDS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22999411 ↗InjuryAug 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 BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22708632 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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