Plexa S 60Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Plexa S 60 is a permanently implanted lead (electrode) for a heart defibrillator. The 33 reports mostly describe the lead picking up electrical noise, failing to sense the heartbeat properly, or needing to be capped or taken out — several because of infection. Reports mention 18 injuries and 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
- 33
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04035479133139), received between Aug 6, 2019 and Apr 27, 2026 — classified as 18 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (7 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 Problem14
- Ambient Noise Problem7
- Device Dislodged or Dislocated7
- High Capture Threshold3
- Under-Sensing3
- High impedance2
- Break1
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Unspecified Infection10
- No Known Impact Or Consequence To Patient4
- Cardiac Perforation2
- Endocarditis1
- Implant Pain1
- Perforation1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026High impedance; Ambient Noise Problem
OUT OF RANGE SHOCK IMPEDANCE REPORTED >150 OHMS. NOISE ALSO SEEN ON FAR FIELD SIGNAL. DEVICE 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 25010196 ↗InjuryMar 4, 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 24510050 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23658352 ↗MalfunctionMay 23, 2025Ambient Noise Problem; Ambient Noise Problem
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 22077796 ↗MalfunctionDec 4, 2024Under-Sensing; Under-Sensing
THIS RV LEAD WAS CAPPED DUE TO UNDERSENSING SINCE (B)(6) 2019 IMPLANT. 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 20847179 ↗InjurySep 4, 2024Adverse 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 20141680 ↗InjurySep 25, 2023Adverse 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 17814638 ↗MalfunctionSep 12, 2023Ambient Noise Problem; Ambient Noise Problem
RV LEAD CAPPED DUE TO NOISE FOLLOWING DFT TEST. (DFT TESTED DUE TO LOW R WAVES ). NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731534 ↗MalfunctionFeb 6, 2023Ambient Noise Problem; Ambient 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 16304167 ↗MalfunctionMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD CAPPED DUE TO PATIENT EXPERIENCING POCKET PAIN. THE PATIENT WAS DOWNGRADE TO CRTP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Implant Pain
MAUDE report 13711921 ↗MalfunctionDec 30, 2021Device Sensing Problem; High Capture Threshold; Device Sensing Problem; High Capture Threshold
HM REPORTED RV SENSING AMPLITUDE BELOW LIMIT (LESS THAN 2 MV). SENSING AMPLITUDE HAS BEEN DECREASING SINCE IMPLANT. THERE WAS A SUDDEN INCREASE IN PACING THRESHOLD EARLY (B)(6). THE LEAD WAS REPOSITIONED ON (B)(6) 2021. 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 13122181 ↗InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS RV LEAD WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11838311 ↗MalfunctionMay 10, 2021Under-Sensing; Under-Sensing
RV LEAD WAS EXPLANTED AND REPLACED DUE TO LOW RV SENSING DETECTED THROUGH DEVICE INTERROGATION. RV SENSING WAS LESS THAN 2.0MV. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11802680 ↗MalfunctionMay 3, 2021Low impedance; Ambient Noise Problem; Low impedance; Ambient Noise Problem
LEAD EXPLANTED DUE TO RV LEAD DEMONSTRATING NOISE AND IMPEDANCE DROP. WHOLE NEW SYSTEM IMPLANTED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11766719 ↗InjuryMar 10, 2021Adverse 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 11454269 ↗MalfunctionFeb 8, 2021Mechanical Problem; Under-Sensing; Mechanical Problem; Under-Sensing
IT WAS REPORTED THAT THIS LEAD HAD A GRADUAL DROP IN SENSING OVER TIME, AND THEN A SUDDEN DROP BELOW 2MV IN (B)(6) 2020. THE LEAD WAS CAPPED AFTER THE SCREW WAS NOT ABLE TO BE RETRACTED. 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 11297991 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN 12 DAYS AFTER THE INITIAL IMPLANT. THIS LEAD WAS EXPLANTED AND REPLACED DUE TO AN RV APEX PERFORATION. THE REVISION PROCEDURE WENT WELL AND THE PATIENT WAS DOING WELL THE DAY AFTER REVISION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE FILE WILL BE UPDATED.
Patient problems: Cardiac Perforation
MAUDE report 11127975 ↗MalfunctionDec 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD DISLODGED ONE DAY AFTER IMPLANT. PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, HOWEVER THEY DISCOVERED TISSUE IN HELIX AND THEREFORE CHOSE TO IMPLANT NEW LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10938629 ↗InjuryNov 10, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated
LEAD WAS EXPLANTED DUE TO DISLODGEMENT, INAPPROPRIATE SHOCKS, AND OVERSENSING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10819969 ↗InjuryOct 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT AND POSSIBLE MICRO PERFORATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Perforation
MAUDE report 10720814 ↗MalfunctionSep 25, 2020Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold
DEVICE INTERROGATION ON (B)(6) 2020 SHOWED HIGH LEAD THRESHOLDS. LEAD WAS FOUND TO BE DISLODGED, AND PATIENT UNDERWENT REVISION ON (B)(6) 2020. 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 10590809 ↗InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD WAS REVISED DUE TO DISLODGEMENT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10491400 ↗MalfunctionSep 2, 2020Break; Ambient Noise Problem; Break; Ambient Noise Problem
NOISE ON LEAD, OUTER INSULATION BREACH. LEAD WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10484021 ↗InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED BECAUSE THE PATIENT SEEMED TO BE ALLERGIC TO THE EPOXY AND RESINS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Skin Inflammation
MAUDE report 10393590 ↗MalfunctionJun 15, 2020High impedance; High Capture Threshold; High impedance; High Capture Threshold
LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS AND IMPEDANCES. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10155374 ↗
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.