Plexa ProMRI DF-1 S DX 65/15Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
All models of Plexa ProMRI (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Plexa ProMRI lead is a permanent defibrillator lead. Its 651 reports mostly describe electrical noise on the lead, with some reports of inappropriate shocks and leads being removed. The reports include 228 injuries and no deaths. 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
- 652
- Deaths reported
- 0
- Injuries reported
- 227
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 652 adverse event reports that list this exact device (DI 04035479151027), received between Jun 14, 2018 and Sep 30, 2026 — classified as 227 injuries, 425 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (283 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem283
- Adverse Event Without Identified Device or Use Problem107
- Inappropriate/Inadequate Shock/Stimulation91
- Over-Sensing81
- Fracture64
- High impedance64
- Device Dislodged or Dislocated55
- High Capture Threshold25
Patient problems
- No Clinical Signs, Symptoms or Conditions348
- No Known Impact Or Consequence To Patient92
- Shock from Patient Lead(s)90
- Unspecified Infection90
- Twiddlers Syndrome14
- Ventricular Fibrillation6
- Cardiac Perforation4
- Pocket Erosion4
Recent adverse event reports
The 25 most recent of 652 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Ambient Noise Problem; Device Sensing Problem; Unstable Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955015 ↗InjurySep 29, 2026Fracture; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940688 ↗MalfunctionSep 29, 2026Ambient Noise Problem
HMSC reported recordings showing noise which resulted in VF detections. RV short interval counter increased >249. All other lead trends appear stable. Lead currently 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 50932652 ↗InjurySep 25, 2026Ambient Noise Problem
Lead was explanted 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 50898907 ↗InjuryAug 13, 2026Ambient Noise Problem; Impedance Problem
This lead was explanted due to noise and impedance out of range. 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 50235091 ↗MalfunctionJul 30, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084179 ↗InjuryJul 7, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS 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 25739111 ↗MalfunctionJun 29, 2026Ambient Noise Problem
ATRIAL MONITORING RECORDING FROM (B)(6) 2026 SHOWS HIGH FREQUENCY NOISE ON THE RA AND FF CHANNELS. RV CHANNEL IS CLEAN. SUSPECTED EMI. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652974 ↗InjuryJun 10, 2026Impedance Problem; Unstable Capture Threshold
LEAD WAS CAPPED DUE TO IMPEDANCE AND THRESHOLD OUT OF RANGE. 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 25461207 ↗InjuryJun 9, 2026Break; Ambient Noise Problem; Impedance Problem
THIS RV LEAD WAS EXPLANTED DUE TO NOISE, HIGH PACING IMPEDANCE, INCREASING SHOCK IMPEDANCE AND IS-1 PIN DISCONNECTED FROM RING. 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 25451372 ↗MalfunctionJun 9, 2026Ambient Noise Problem
NOISE IS EVIDENT ON RV CHANNEL AND FF CHANNEL. SOME NOISE IS REPORTED ON ATRIAL CHANNEL. SHORT INTERVAL COUNTER SHOWS ABOVE 249. FULL LEAD EVALUATION IS RECOMMENDED. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451254 ↗InjuryJun 4, 2026Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO ATRIAL AND VENTRICULAR 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 25401395 ↗InjuryMay 21, 2026Ambient Noise Problem; Device Dislodged or Dislocated; High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT RESULTING IN HIGH RV THRESHOLD AND RA NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25245772 ↗InjuryMay 20, 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 25234686 ↗InjuryMay 5, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
NOISE ON FF, RA, AND RV CHANNELS LEADING TO INAPPROPRIATE SHOCK DELIVERED. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25088507 ↗InjuryApr 30, 2026Over-Sensing; Ambient Noise Problem
NOISE ON LEAD. RV NOISE CAUSED OVER SENSING. THE LEAD WAS CAPPED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25051726 ↗MalfunctionApr 22, 2026Ambient Noise Problem
HMSC REPORTED EPISODES SHOWING NOISE ON THE RV CHANNEL. TREND GRAPHS SHOW INCREASES IN SHORT INTERVAL COUNTER. ALL OTHER LEAD TRENDS APPEAR STABLE. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952735 ↗InjuryApr 17, 2026Over-Sensing; Ambient Noise Problem
LEAD WAS CAPPED DUE TO NOISE OVERSENSING. 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 24915839 ↗InjuryApr 14, 2026Ambient Noise Problem
NOISE SEEN DURING THRESHOLD TESTING. PACE/SENSE PORTION OF LEAD CAPPED AND CSP LEAD IMPLANTED. SHOCKING PORTION OF LEAD REMAINS ACTIVE AND ATTACHED TO NEW HFT DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872345 ↗MalfunctionApr 14, 2026Fracture; Ambient Noise Problem
PATIENT HAD WHAT APPEARED TO BE TRUE EPISODES OF AT/VT FOLLOWED BY A JUMP IN RV SHORT INTERVALS AND NST/VF EPISODES SHOWING LEAD NOISE ON ALL CHANNELS (B)(6) 2023. LAST MESSAGE ON HOME MONITORING WAS (B)(6) 2023. NO IMPEDANCE TRENDS OBSERVED. THE NOISE COULD BE REPRODUCED AND A FRACTURE IS POSSIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872191 ↗InjuryApr 13, 2026Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867780 ↗MalfunctionApr 9, 2026Ambient Noise Problem
NOISE ON THE RV AND FF CHANNELS CAN BE SEEN. THE NOISE ON THE RV CHANNEL BEGAN CAUSING INAPPROPRIATE NST DETECTIONS ON (B)(6) 2026. TWO INAPPROPRIATE VF DETECTIONS WERE MADE DUE TO NOISE, BUT SHOCKS WERE ABORTED IN BOTH CASES. INTERMITTENT NOISE COULD BE RECREATED IN PERSON ON (B)(6) 2026. NO ADVERSE EVENTS REPORTED. LEAD REMAINS IMPLANTED. IT WAS REPORTED THE PATIENT HAD A HEART CATHETERIZATION ON (B)(6) 2026. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835850 ↗MalfunctionMar 30, 2026Ambient Noise Problem
NOISE IS EVIDENT ON RV CHANNEL AND FAR FIELD CHANNEL. LEAD CURRENTLY 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 24720498 ↗InjuryMar 26, 2026Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED DUE TO PATIENT HAD A MOTOR VEHICLE ACCIDENT WITH LEFT SHOULDER INJURY AND SUBSEQUENT LEAD NOISE. ICD THERAPIES HAD BEEN PROGRAMMED OFF SINCE FALL 2025. 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 24698862 ↗MalfunctionMar 24, 2026Ambient Noise Problem
SHORT INTERVAL COUNT ELEVATED ON RV LEAD COMPLEXES APPEAR ON BOTH RV CHANNEL AND FAR FIELD CHANNEL. 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 24675710 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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