Plexa ProMRI DF-1 S DX 65/17Recalls & 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 defibrillator electrode lead is an implanted heart lead. Of its 172 reports, 66 are filed as injuries, and many describe electrical noise and high readings from the lead, along with fractures and dislodging. Several describe the lead or system being removed due to infection, fracture, or inappropriate shocks. The reports mention no deaths, and 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
- 175
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 04035479151034), received between Aug 11, 2018 and Sep 29, 2026 — classified as 68 injuries, 107 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (61 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 Problem61
- Adverse Event Without Identified Device or Use Problem50
- High impedance20
- Device Dislodged or Dislocated18
- Fracture17
- Over-Sensing12
- Inappropriate/Inadequate Shock/Stimulation11
- High Capture Threshold10
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- Unspecified Infection47
- No Known Impact Or Consequence To Patient26
- Shock from Patient Lead(s)13
- Pocket Erosion2
- Twiddlers Syndrome2
- Ventricular Fibrillation2
- Cardiac Arrest1
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926790 ↗InjurySep 11, 2026Impedance Problem
This lead was capped due to high/varying shock impedance. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733570 ↗MalfunctionSep 2, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576310 ↗InjuryAug 11, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This lead was explanted due to noise and inappropriate shocks. No adverse patient events were reported. Should additional information become available, this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50203571 ↗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 25682154 ↗InjuryJun 1, 2026Fracture
THIS LEAD WAS EXPLANTED BECAUSE IT WAS FRACTURED. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348517 ↗MalfunctionApr 8, 2026High impedance
RV LEAD SHOCK IMPEDANCE HAS BEEN GRADUALLY CLIMBING OVER THE YEAR AND IS NOW 126 OHMS. OTHER STATISTICS APPEAR WITHIN NORMAL LIMITS. 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 24822753 ↗InjuryMar 30, 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 24736462 ↗InjuryMar 12, 2026Fracture
THIS LEAD WAS EXPLANTED DUE TO 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 24583577 ↗InjuryJan 19, 2026Fracture
THIS LEAD WAS EXPLANTED DUE TO FRACTURE. 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 24108511 ↗MalfunctionDec 30, 2025High impedance; High impedance
THIS LEAD SHOWS HIGH SHOCK IMPEDANCE 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 23921955 ↗MalfunctionDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS CAPPED DUE TO DISLODGEMENT WHICH WAS CAUSED BY PATIENT NON-COMPLIANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905751 ↗MalfunctionNov 26, 2025Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE AND POSSIBLE FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658200 ↗MalfunctionNov 25, 2025Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE AND POSSIBLE 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 23648184 ↗MalfunctionNov 17, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold
THIS LEAD WAS PARTIALLY CAPPED WITH THE TACHY PIN AND THE RV PACE SENSE PIN CAPPED. PACING IMPEDANCE AND SHOCK IMPEDANCE WERE OUT OF RANGE, AND THRESHOLD WAS ELEVATED. MD ELECTED TO IMPLANT A NEW DF-4 TACHY LEAD AND UTILIZE THE EXISTING ATRIAL DIPOLE FROM THE DF-1 TACHY LEAD. 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 23570360 ↗MalfunctionNov 14, 2025Fracture; Fracture
THIS LEAD WAS CAPPED DUE TO AN INSULATION ISSUE. 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 23554416 ↗MalfunctionNov 12, 2025High impedance; High impedance
THIS LEAD WAS CAPPED DUE TO SHOCK IMPEDANCE WAS GREATER THAN 150OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23537709 ↗MalfunctionNov 7, 2025High impedance; High impedance
THIS LEAD WAS CAPPED DUE TO IMPEDANCE GREATER THAN 3000 OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496595 ↗MalfunctionNov 5, 2025Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE AND IMPEDANCE ISSUES. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23481076 ↗MalfunctionNov 4, 2025Fracture; Fracture
THIS 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 23471981 ↗MalfunctionAug 11, 2025Ambient Noise Problem; Ambient Noise Problem
NOISE SEEN ON THE RV AND FAR FIELD CHANNELS IN RV LEAD MONITORING RECORDINGS. NOISE SEEMS TO HAVE BEGUN BACK IN 2023. NO INAPPROPRIATE DETECTIONS OR SHOCKS HAVE BEEN DELIVERED. IT WAS REPORTED BY THE REPS THAT THE PHYSICIAN AND PATIENT ARE AWARE OF THE RISKS AND ARE CHOOSING NOT TO REVISE THE LEAD OR TAKE ANY COURSE OF ACTION AT THIS TIME. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771622 ↗MalfunctionJul 31, 2025High impedance; High impedance
SHOCK IMPEDANCE GREATER THAN 150 OHMS SEEN ON HOME MONITORING. PATIENT BROUGHT INTO OFFICE AND MEASUREMENTS ALSO THE SAME. ISOMETRIC TESTING DID NOT PRODUCE NOISE, NO NOISE ON RECORDINGS, AND ALL OTHER TRENDS AND TESTING WERE NORMAL. CLINICIAN WILL PRESENT INFORMATION TO PHYSICIAN FOR NEXT STEPS. LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680855 ↗MalfunctionJul 30, 2025Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED 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 22663539 ↗MalfunctionJun 26, 2025Fracture; Fracture
THIS LEAD WAS EXPLANTED 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 22335595 ↗MalfunctionJun 11, 2025Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED 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 22187434 ↗
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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