Plexa ProMRI DF-1 S 65Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Plexa ProMRI DF-1 S65 is an implanted permanent defibrillator lead, the wire that carries shock therapy to the heart. The 65 reports mostly describe leads that picked up stray signals or background noise, shifted position after implantation, or showed rising electrical resistance, and several mention infection that led to the whole system being taken out. Reports include 2 deaths and 21 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
- 65
- Deaths reported
- 2
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 04035479150969), received between May 3, 2019 and Jun 30, 2026 — classified as 2 deaths, 21 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (12 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
- Adverse Event Without Identified Device or Use Problem16
- Over-Sensing12
- Device Dislodged or Dislocated9
- Ambient Noise Problem6
- Impedance Problem6
- High impedance5
- Break3
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Unspecified Infection13
- No Known Impact Or Consequence To Patient6
- Shock from Patient Lead(s)2
- Cardiac Perforation1
- Cardiac Tamponade1
- Chest Pain1
- Death1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 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 25667269 ↗InjuryApr 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 24867756 ↗InjuryMar 10, 2026Device Dislodged or Dislocated
THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564159 ↗MalfunctionFeb 23, 2026Impedance Problem
HMSC REPORTED SHOCK IMPEDANCE GRADUALLY INCREASING OVER THE PAST YEAR. ALL OTHER LEAD TRENDS WERE UNREMARKABLE. NO NOISE EVIDENT. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24420977 ↗InjuryFeb 3, 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 24249119 ↗MalfunctionNov 5, 2025Fracture; Fracture
THE P/S PORTION OF THIS LEAD WAS CAPPED 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 23478441 ↗InjuryNov 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23472100 ↗InjuryAug 19, 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22844226 ↗MalfunctionJul 21, 2025High impedance; High impedance
THIS LEAD WAS CAPPED DUE TO CHRONIC HIGH IMPEDANCE, >3000 OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561347 ↗MalfunctionJul 15, 2025Break; Impedance Problem; Break; Impedance Problem
LEAD WAS EXPLANTED AND REPLACED BECAUSE OF OOR B COIL (RV) IMPEDANCE. UPON POCKET OPENING, THE RV COIL (DF1) SEGMENT WAS COMPLETELY SEPARATED FROM THE LEAD AT EXACTLY THE LEAD YOKE EXIT. THE LEAD SEGMENT APPEARED TO BE CUT. 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 22515585 ↗InjuryJan 23, 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21224652 ↗MalfunctionJan 13, 2025Device Sensing Problem; Device Sensing Problem
THE PACING PORTION OF THIS LEAD WAS CAPPED DUE TO NO SENSING WITH FINE VF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21145493 ↗MalfunctionJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113835 ↗InjuryJun 20, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THIS RV LEAD WAS EXPLANTED AFTER FAILED ATTEMPT TO REPOSITION LEAD DUE TO HELIX WOULD NOT RETRACT. PATIENT HAD HAD A SYNCOPAL EPISODE AND VF WITH FAILED ICD SHOCK, AND DURING (B)(6) 2024 EP VISIT FOR CARDIOVERSION, DFT RESULTED IN THREE FAILED SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Syncope/Fainting; Ventricular Fibrillation
MAUDE report 19577102 ↗MalfunctionMay 20, 2024Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE POSSIBLY FROM FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354772 ↗MalfunctionApr 25, 2024Ambient Noise Problem; Ambient Noise Problem
RV LEAD IS SHOWING NOISE VIA HOME MONITORING. ALL LEAD TRENDS APPEAR STABLE. LEAD TO BE EVALUATED FURTHER. LEAD CURRENTLY REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19185416 ↗MalfunctionMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921680 ↗InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ICD AND RV LEAD WERE EXPLANTED DUE TO POCKET INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 18866754 ↗MalfunctionOct 17, 2023Ambient Noise Problem; Ambient Noise Problem
NOISE SEEN ON FAR FIELD SIGNAL. DISCUSSED POSSIBILITY OF EXTERNAL EMI OR LEAD INSULATION ISSUES. PATIENT WILL BE BROUGHT IN FOR FURTHER EVALUATION AND DISCUSSION WITH EP. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17953902 ↗MalfunctionJun 28, 2023Ambient Noise Problem; Ambient Noise Problem
THIS LEAD SHOWS NOISE. DEVICE 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 17218062 ↗MalfunctionJun 12, 2023High impedance; High impedance
LEAD SHOWED HIGH SHOCK IMPEDANCE (>150 OHMS) UPON DISCHARGE CHECK. PATIENT RETURNED TO HOSPITAL ON (B)(6) 2023 AND THE SET SCREW WAS TIGHTENED WHICH RESOLVED THE IMPEDANCE ISSUE. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114021 ↗InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15886470 ↗MalfunctionOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT FOUND BY X-RAY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15620955 ↗InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 15417264 ↗MalfunctionJun 22, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED DUE TO OVERSENSING APPROX. 14 MONTHS AFTER THE IMPLANTATION. 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 14783258 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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