Plexa ProMRI S 65Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Plexa ProMRI S 65 is a wire-like electrode implanted in the heart for defibrillator therapy. Its 1,591 reports mention electrical noise that the device picks up, and many describe unwanted shocks, leads moving out of place, breakage or infection. The reports mention 9 deaths and 654 injuries. 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
- 1,592
- Deaths reported
- 9
- Injuries reported
- 652
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,592 adverse event reports that list this exact device (DI 04035479140021), received between Jun 15, 2018 and Sep 30, 2026 — classified as 9 deaths, 652 injuries, 931 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (447 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem447
- Adverse Event Without Identified Device or Use Problem405
- Over-Sensing273
- Inappropriate/Inadequate Shock/Stimulation193
- Device Dislodged or Dislocated156
- Fracture119
- High impedance117
- High Capture Threshold67
Patient problems
- No Clinical Signs, Symptoms or Conditions750
- Unspecified Infection335
- No Known Impact Or Consequence To Patient201
- Shock from Patient Lead(s)194
- Pocket Erosion22
- Cardiac Perforation20
- Twiddlers Syndrome19
- Endocarditis11
Recent adverse event reports
The 25 most recent of 1,592 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954937 ↗InjurySep 29, 2026Fracture; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932650 ↗MalfunctionSep 25, 2026Ambient Noise Problem
RV lead noise was reported. Lead is currently implanted. 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 50899519 ↗InjurySep 16, 2026Impedance Problem
This lead was explanted due to increasing impedance over time. 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 50787689 ↗MalfunctionSep 16, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787588 ↗MalfunctionSep 2, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569118 ↗InjuryAug 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 50278393 ↗InjuryAug 10, 2026Adverse 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 50199136 ↗InjuryJul 6, 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 25727739 ↗InjuryJul 2, 2026Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696624 ↗InjuryJul 1, 2026Adverse 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 25681835 ↗MalfunctionJun 22, 2026Ambient Noise Problem
INCREASED FREQUENCY OF RANDOM NOISE SEEN ON VENTRICULAR SENSING CHANNEL. ALSO, INTERMITTENT INCREASE IN VENTRICULAR STIMULATION THRESHOLD NOTED. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588027 ↗InjuryJun 17, 2026Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED DUE TO FRACTURE, HIGH IMPEDANCE AND NOISE RESULTING IN INAPPROPRIATE SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25539973 ↗MalfunctionJun 10, 2026Low impedance; Ambient Noise Problem; Device Sensing Problem
THE ONSET OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL BEGINNING (B)(6) 2026 WAS REPORTED. SINCE THAT TIME, THERE HAS BEEN A MARKED ACUTE INCREASE IN SHORT RV INTERVAL COUNTS, ALONG WITH NOISE EVIDENT ON THE RV CHANNEL DURING RECORDED EPISODES. RV PACING IMPEDANCE HAS TRIGGERED AN ALERT FOR A LOW OUT-OF-RANGE VALUE (<200 OHMS). ADDITIONALLY, RV SENSING AMPLITUDE HAS SHOWN A DOWNWARD TREND SINCE LATE (B)(6). TREND DATA INDICATE THAT RV PACING THRESHOLDS AND SHOCK IMPEDANCES REMAIN STABLE AND WITHIN NORMAL LIMITS. THE LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461262 ↗MalfunctionJun 9, 2026Fracture; Ambient Noise Problem
LEAD SHOWS NOISE AND SUSPECTED FRACTURE. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451283 ↗InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND NOISE WAS SEEN ON LEAD. MULTIPLE EPISODES OF NOISE WERE LOGGED IN THE DAYS PRIOR TO THE SHOCK. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25436336 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO SUSPECTED INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25427913 ↗InjuryJun 1, 2026Fracture; Ambient Noise Problem
RV LEAD WAS CAPPED DUE TO NOISE WITH LIKELY INSULATION DEGRADATION. 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 25354358 ↗InjuryJun 1, 2026Ambient Noise Problem; Impedance Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE AND SHARP DROPS IN 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 25354327 ↗InjuryJun 1, 2026Ambient Noise Problem
RV LEAD WAS CAPPED DUE TO NOISE. 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 25349066 ↗InjuryMay 26, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE RESULTING IN INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25286029 ↗MalfunctionMay 26, 2026Ambient Noise Problem
LEAD NOISE SEEN ON HOME MONITORING RECORDINGS. LEAD REMAINS IMPLANTED. 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 25277893 ↗InjuryMay 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 25249750 ↗InjuryMay 20, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD WAS CAPPED DUE TO NOISE/FAILURE CAUSING INAPPROPRIATE SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25233675 ↗InjuryMay 19, 2026Fracture; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE FROM 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 25216581 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.