Plexa ProMRI SD 65/18Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This BIOTRONIK Plexa ProMRI defibrillator lead has 296 reports, including 156 injuries and no deaths. Many describe electrical noise on the lead, and some describe the lead moving out of place, breaking, or giving unwanted shocks. Infections are mentioned in many reports, and some systems were removed after blood infections or an infection of the heart's inner lining. 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
- 294
- Deaths reported
- 0
- Injuries reported
- 156
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 04035479139995), received between Jul 2, 2018 and Aug 31, 2026 — classified as 156 injuries, 138 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (88 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 Problem115
- Ambient Noise Problem88
- Device Dislodged or Dislocated26
- High impedance25
- Inappropriate/Inadequate Shock/Stimulation25
- Fracture24
- Over-Sensing15
- Device Sensing Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions120
- Unspecified Infection98
- No Known Impact Or Consequence To Patient25
- Shock from Patient Lead(s)25
- Cardiac Perforation6
- Twiddlers Syndrome5
- Endocarditis4
- Pocket Erosion4
Recent adverse event reports
The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Ambient Noise Problem
This 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 50527633 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to endocarditis. Should additional information be received this file will be updated.
Patient problems: Endocarditis
MAUDE report 50437870 ↗MalfunctionAug 3, 2026Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116849 ↗MalfunctionJun 23, 2026Ambient Noise Problem
CLINICIAN REPORTED LEAD DISPLAYING NOISE ON RECORDINGS. PHYSICIAN DIRECTED TACHY THERAPY TO BE DISABLED AND SENSITIVITY BE PROGRAMMED LEAST SENSITIVE FOR BRADY. PATIENT IS DEPENDENT. 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 25595978 ↗MalfunctionJun 8, 2026Low impedance; Ambient Noise Problem
THIS LEAD SHOWS LOW PACING IMPEDANCE AND NOISE. 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 25436186 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BLOOD INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25376870 ↗InjuryJun 1, 2026Fracture
LEAD WAS CAPPED 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 25348973 ↗InjuryMay 21, 2026Ambient Noise Problem
THIS 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 25246988 ↗InjuryMay 15, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THE PATIENT HAD PRESENTED TO THE HOSPITAL AFTER RECEIVING SHOCK THERAPY. NOISE HAD BEEN DETECTED, AND INAPPROPRIATE THERAPY DUE TO OVERSENSING. MULTIPLE SHOCKS HAD BEEN DELIVERED, AND THE DEVICE HAD REACHED EOS. DEVICE AND LEAD WERE EXPLANTED AND RETURNED FOR ANALYSIS.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25187191 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 25162431 ↗InjuryMay 5, 2026Ambient Noise Problem; Device Sensing Problem
HMSC REPORTED EPISODES SHOWING NOISE RESULTING IN INAPPROPRIATE NON-SUSTAINED VT EPISODES. LEAD TRENDS SHOW A DROP IN MINIMUM SENSING AMPLITUDE AND UNSUCCESSFUL THRESHOLD TESTS. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085097 ↗InjuryApr 8, 2026Fracture; Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE AND LIKELY FRACTURE. NO OTHER 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 24822584 ↗InjuryMar 11, 2026Patient-Device Incompatibility; Impedance Problem
LEAD WAS EXPLANTED DUE TO SHOCK IMPEDANCE FAILURE. APPEARED TO BE CLAVICULAR CRUSH. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571976 ↗InjuryMar 4, 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 24514045 ↗InjuryFeb 23, 2026Device Dislodged or Dislocated
THIS RV 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 24416282 ↗InjuryFeb 23, 2026Fracture; Impedance Problem
THIS RV LEAD WAS CAPPED DUE TO ELEVATED IMPEDANCE INDICATING A 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 24413703 ↗InjuryFeb 17, 2026Over-Sensing; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE/OVERSENSING. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365626 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO SEPSIS/INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24268701 ↗MalfunctionDec 15, 2025Ambient Noise Problem; Ambient Noise Problem
THIS 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 23812122 ↗InjuryNov 25, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE AND INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23645767 ↗MalfunctionNov 18, 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 23587522 ↗MalfunctionNov 17, 2025Pacing Intermittently; Ambient Noise Problem; Pacing Intermittently; Ambient Noise Problem
LEAD WAS CAPPED DUE TO SHOWING NOISE AND PACING INHABITATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568945 ↗MalfunctionNov 10, 2025Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem
PATIENT HAS NOISE ON NEAR FIELD OF RV LEAD. HM REPORTS NUMEROUS FAST NST RECORDINGS. DEVICE THERAPY WAS TURNED OFF ON (B)(6) 2025. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23518545 ↗InjuryOct 29, 2025Inappropriate/Inadequate Shock/Stimulation; Low impedance; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Ambient Noise Problem
THIS LEAD SHOWS NOISE WHICH LED TO INAPPROPRIATE SHOCKS. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23413161 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION FROM PORT WHEN GETTING IV TREATMENT AT HOME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23348358 ↗
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.