Plexa ProMRI S DX 65/15Recalls & 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 lead has 759 reports, with 1 death and 358 injuries. Many reports describe the lead shifting out of place, electrical noise on the lead, and sensing problems, and several describe the lead being removed due to infection or pocket erosion. 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
- 762
- Deaths reported
- 1
- Injuries reported
- 360
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 762 adverse event reports that list this exact device (DI 04035479158781), received between Aug 9, 2019 and Sep 25, 2026 — classified as 1 death, 360 injuries, 401 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (174 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 Problem287
- Device Dislodged or Dislocated174
- Ambient Noise Problem166
- High impedance52
- Inappropriate/Inadequate Shock/Stimulation43
- Device Sensing Problem38
- Fracture35
- High Capture Threshold35
Patient problems
- No Clinical Signs, Symptoms or Conditions346
- Unspecified Infection239
- No Known Impact Or Consequence To Patient44
- Shock from Patient Lead(s)39
- Twiddlers Syndrome27
- Cardiac Perforation17
- Sepsis10
- Pocket Erosion7
Recent adverse event reports
The 25 most recent of 762 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This lead was explanted due to fracture resulting in noise and inappropriate shocks. Should additional information be received this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50899335 ↗InjurySep 24, 2026Ambient Noise Problem
This 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 50889995 ↗InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
This lead was explanted due to failed shock and undersensing VF. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787437 ↗InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Low impedance; Ambient Noise Problem
Multiple inappropriate shocks delivered due to noise on the rv lead. Device remains implanted. Should additional information be received, this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50782703 ↗InjurySep 10, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Shock from Patient Lead(s)
MAUDE report 50724050 ↗MalfunctionSep 3, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599294 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50569218 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
System explanted due to pocket erosion. Should additional information be received, this file will be updated.
Patient problems: Pocket Erosion
MAUDE report 50278390 ↗InjuryAug 13, 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 50234039 ↗InjuryAug 13, 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 50233991 ↗MalfunctionAug 7, 2026Ambient Noise Problem
Noise seen on the RV channel in a fast nsT recording transmitted to Home Monitoring. Noise was not seen on the RA or LV channels. Patient mentioned they may have been welding at the time. Full lead evaluation with postural testing and isometrics was recommended. Lead remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179931 ↗MalfunctionAug 4, 2026High impedance; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134312 ↗InjuryJun 24, 2026Ambient Noise Problem; Device Dislodged or Dislocated
THIS RV LEAD WAS EXPLANTED DUE TO DISLODGEMENT RESULTING IN NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611799 ↗InjuryJun 24, 2026High impedance
THE RV LEAD WAS CAPPED DUE TO AN IMPEDANCE GREATER THAN 2500OHMS. 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 25611741 ↗InjuryJun 23, 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 25601290 ↗InjuryJun 22, 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 25585235 ↗MalfunctionJun 4, 2026Ambient Noise Problem
NOISE REPORTED ON RECORDINGS SHOWN ON FARFIELD CHANNEL AND ATRIAL CHANNEL, BEGINNING (B)(6) 2026. 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 25397906 ↗MalfunctionJun 4, 2026Ambient Noise Problem; Device Sensing Problem
NOISE AND LOW SENSING AMPLITUDE CAN BE SEEN ON HMSC RECORDINGS BEGINNING IN (B)(6) 2023. THE PATIENT WILL BE BROUGHT IN FOR REPROGRAMMING. NO ADVERSE EVENTS REPORTED, LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393173 ↗InjuryJun 3, 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 25376872 ↗MalfunctionJun 1, 2026Failure to Capture; Ambient Noise Problem; Device Sensing Problem
LOSS OF CAPTURE EVENTS SEEN ON THE RV CHANNEL. SMALL DEFLECTIONS COULD BE SEEN UPON REVIEW SUGGESTING CAPTURE EXCEPT FOR ON ONE PACED EVENT; HOWEVER, NO INTRINSIC EVENT CONDUCTED, SO THE ASSESSMENT IS ISOELECTRIC CAPTURE. NOISE COULD BE SEEN ON THE FARFIELD, ATRIAL AND VENTRICULAR CHANNELS SIMULTANEOUSLY, SUGGESTING POSSIBLE EMI. HOWEVER THERE WAS SIGNIFICANT ATRIAL UNDERSENSING AS WELL AS OTHER RECORDINGS WITH PIXELATED FARFIELD SIGNAL, POSSIBLY SUGGESTING LEAD INTEGRITY ISSUE. LEAD CURRENTLY REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348771 ↗InjuryMay 26, 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 25284162 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO BACTEREMIA INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 25283592 ↗InjuryMay 18, 2026Ambient Noise Problem
THE SHOCKING PORTION OF THIS LEAD WAS CAPPED DUE TO NOISE. PACE/SENSE PORTION STILL IN USE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210887 ↗InjuryMay 12, 2026Break; Low impedance; Ambient Noise Problem
NOISE IS EVIDENT ON RV LEAD. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148591 ↗InjuryMay 5, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE, INAPPROPRIATE SHOCKS, PACING IMPEDANCE >3K. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25080828 ↗
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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