Protego S 60 379970Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Protego S 60 defibrillator lead is a wire that connects a heart defibrillator to the heart. Many of the 113 reports describe electrical noise on the lead, which can lead to inappropriate shocks, and some describe the lead fracturing or showing abnormal electrical resistance. Several leads were removed or capped. The reports include 45 injuries and no deaths, and 19 list an infection. 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
- 113
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 04035479121495), received between Dec 9, 2016 and Sep 11, 2026 — classified as 45 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (53 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem53
- Adverse Event Without Identified Device or Use Problem21
- Fracture21
- Inappropriate/Inadequate Shock/Stimulation20
- High impedance15
- High Capture Threshold5
- Break4
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Known Impact Or Consequence To Patient22
- Shock from Patient Lead(s)20
- Unspecified Infection19
- Pocket Erosion2
- Cardiopulmonary Arrest1
- Failure of Implant1
- Myocarditis1
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Ambient Noise Problem
This lead was capped 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 50733569 ↗InjuryAug 12, 2026Fracture
This lead was capped due to suspected lead 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 50230169 ↗InjuryJun 24, 2026Ambient Noise Problem
THIS RV LEAD WAS CAPPED 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 25610663 ↗InjuryApr 13, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS RV LEAD HAD NOISE LEADING TO INAPPROPRIATE SHOCKS. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24867727 ↗InjuryMar 5, 2026Impedance Problem
THIS RV LEAD WAS EXPLANTED DUE TO STRONG, RAPID DEVIATIONS OF LEAD IMPEDANCE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24515658 ↗MalfunctionJan 21, 2026Ambient Noise Problem
NOISE CAN BE SEEN ON THE RV CHANNEL LEADING TO AN INAPPROPRIATE NST DETECTION. THE SHORT RV INTERVAL COUNTER BEGAN INCREMENTING ON (B)(6) 2026. NO NOISE COULD BE REPRODUCED IN PERSON ON (B)(6) 2026 AFTER PERFORMING POSTURAL AND ISOMETRIC TESTING. ALL LEAD TRENDS ARE STABLE AND WITHIN NORMAL RANGE. LEAD REMAINS IMPLANTED, NO ADVERSE EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24137063 ↗InjuryJan 5, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation
THIS RV LEAD WAS EXPLANTED DUE TO FRACTURE WITH INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23967253 ↗MalfunctionDec 3, 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 23711558 ↗MalfunctionOct 15, 2025Fracture; Fracture
THIS RV 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 23306219 ↗MalfunctionSep 10, 2025Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem
HMSC REPORTED EPISODES SHOWING LOSS OF CAPTURE. SHOCK IMPEDANCE TREND INCREASING. ADVISED FURTHER LEAD EVALUATION. 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 23021446 ↗MalfunctionAug 12, 2025Ambient Noise Problem; Ambient Noise Problem
NOISE WAS REPORTED ON THE RV CHANNEL. TACHY THERAPIES HAVE BEEN DISABLED AND PHYSICIAN WILL BE CONSULTED FOR NEXT STEPS. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782062 ↗MalfunctionAug 5, 2025Fracture; Fracture
THIS LEAD WAS CAPPED DUE TO FRACTURED LEAD. 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 22723326 ↗MalfunctionJul 18, 2025Ambient Noise Problem; Ambient Noise Problem
HM REVEALED NOISE POTENTIALS PRE AND POST QRS. LEAD REMAINS IMPLANTED AND PATIENT TO BE BROUGHT IN FOR IN OFFICE F/U. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541238 ↗InjuryJul 9, 2025Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. LEAD FRACTURE AND NOISE WAS ALSO NOTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22459085 ↗MalfunctionJun 27, 2025Ambient Noise Problem; Ambient Noise Problem
THIS RV 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 22346906 ↗MalfunctionApr 17, 2025Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21856076 ↗InjuryFeb 6, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE LEADING TO INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 21327356 ↗MalfunctionJan 24, 2025High impedance; Over-Sensing; High Capture Threshold; High impedance; Over-Sensing; High Capture Threshold
RV LEAD WAS CAPPED AND REPLACED DUE TO HIGH PACING IMPEDANCE (>200 OHMS). OVERSENSING AND HIGH THRESHOLD ALSO NOTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229345 ↗InjuryNov 8, 2024Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD HAD SIGNS OF FRACTURE. ONE INAPPROPRIATE SHOCK DELIVERED DUE TO NOISE. LEAD WAS EXPLANTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 20640518 ↗InjuryOct 3, 2024Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE AND INAPPROPRIATE SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 20363839 ↗MalfunctionSep 18, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
LEAD WAS CAPPED DUE TO DISLODGEMENT AND FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252430 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS LEAD WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 19761849 ↗MalfunctionApr 18, 2024Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem
LEAD WAS EXPLANTED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19140226 ↗InjuryApr 3, 2024Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED 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 19030978 ↗MalfunctionMar 28, 2024Ambient Noise Problem; Ambient Noise Problem
EXTRA SYSTOLES NOTED ON NEAR FIELD IEGM THAT IS REPRODUCIBLE, SHOWING NOISE. LEAD REMAINS IMPLANTED. MD STATED LEAD WILL NEED TO BE CHANGED OUT IN NEAR FUTURE WITH GENERATOR CHANGE OUT. 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 18997786 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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