Protego S 65 379969Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Protego S 65 defibrillator lead has 388 reports in the FDA database, with 150 injuries and no deaths. Many reports describe electrical noise being read as false signals, which can lead to inappropriate shocks, and some describe fractured leads or high electrical resistance. Some patients felt shocks from the lead, and some leads were switched off (capped). 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
- 393
- Deaths reported
- 0
- Injuries reported
- 153
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 393 adverse event reports that list this exact device (DI 04035479121488), received between Oct 6, 2017 and Sep 16, 2026 — classified as 153 injuries, 240 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (218 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
- Ambient Noise Problem218
- Inappropriate/Inadequate Shock/Stimulation87
- Fracture76
- Adverse Event Without Identified Device or Use Problem55
- High impedance45
- Over-Sensing32
- Impedance Problem14
- Low impedance13
Patient problems
- No Clinical Signs, Symptoms or Conditions199
- Shock from Patient Lead(s)88
- No Known Impact Or Consequence To Patient56
- Unspecified Infection49
- Twiddlers Syndrome4
- Pocket Erosion2
- Sepsis2
- Ventricular Fibrillation2
Recent adverse event reports
The 25 most recent of 393 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Ambient Noise Problem
This lead was explanted 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 50792396 ↗MalfunctionSep 16, 2026Ambient Noise Problem
This lead shows noise 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 50789933 ↗InjurySep 8, 2026High impedance
This lead was capped due to increased RV lead impedance showing >3000 ohms. 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 50671257 ↗InjurySep 8, 2026Fracture; Low impedance
This lead was explanted due to insulation failure and impedance <200ohms. 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 50669905 ↗MalfunctionSep 3, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590289 ↗InjuryAug 31, 2026Fracture
This lead was capped due to signs of progressing 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 50527648 ↗InjuryAug 20, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
This RV lead was capped due to noise resulting in inappropriate shock and pace/sense impedance >3000 ohms. Should additional information be received this file will be updated.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50348020 ↗InjuryAug 7, 2026High impedance
Lead was capped due to Pace/sense impedance >3000 ohms. 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 50180370 ↗MalfunctionJun 26, 2026Ambient Noise Problem; Device Sensing Problem
DOUBLE-COUNTED EVENTS SEEN ON THE RV CHANNEL DURING SENSING IN A VF EPISODE AND HIGH SHORT RV INTERVAL COUNT. IMPEDANCE IS UNREMARKABLE AND THE RV CAPTURE CONTROL TEST CONSISTENTLY FAILS SO NO DATA WAS AVAILABLE REGARDING PACING THRESHOLD. FULL LEAD EVALUATION WITH POSTURAL TESTING AND ISOMETRICS WAS RECOMMENDED. LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643769 ↗InjuryMay 11, 2026Ambient Noise Problem
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 25137048 ↗InjuryApr 27, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
NOISE SEEN IN MULTIPLE IEGMS. PATIENT RECEIVED 4 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 25010266 ↗MalfunctionMar 11, 2026Ambient Noise Problem
BRIEF NOISE SEEN ON FF IN ONE IEGM. NO IMPEDANCE OR RV CHANNEL CHANGES. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572108 ↗InjuryMar 2, 2026Ambient Noise Problem
NOISE SEEN ON THIS RV LEAD. NO ADVERSE PATIENT EVENTS WERE REPORTED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483445 ↗InjuryFeb 25, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
RV LEAD NOISE LED TO INAPPROPRIATE VF DETECTION AND INAPPROPRIATE SHOCKS. PATIENT ENDED UP IN EMERGENCY ROOM. LEAD REMAINS IMPLANTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24449976 ↗InjuryFeb 20, 2026Impedance Problem; Unstable Capture Threshold
RV LEAD CAPPED DUE TO THRESHOLD AND IMPEDANCE OUT OF RANGE POST AUTOMOBILE ACCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403467 ↗InjuryFeb 16, 2026Pacing Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE CAUSING INHIBITION OF PACING. 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 24351778 ↗InjuryFeb 10, 2026Fracture
THIS RV 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 24307236 ↗InjuryFeb 10, 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 24303451 ↗InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO BACTEREMIA INFECTION. PATIENT WAS ADMITTED ON (B)(6) 2026, IS STILL HOSPITALIZED, AND ALSO HAS LVAD AND WOUND VAC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia
MAUDE report 24185390 ↗InjuryJan 20, 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 24125300 ↗InjuryJan 20, 2026Ambient Noise Problem; Impedance Problem; Unstable Capture Threshold
THIS LEAD SHOWS NOISE PLUS IMPEDANCE AND THRESHOLD ISSUES. 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 24119887 ↗MalfunctionJan 12, 2026High impedance; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO SHOCK IMPEDANCE >150 OHMS AND NOISE ON RV CHANNEL. 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 24043112 ↗MalfunctionJan 9, 2026Intermittent Capture; Fracture; Over-Sensing; Pacing Problem
THIS RV LEAD WAS CAPPED DUE TO FRACTURE, OVERSENSING, INTERMITTENT LOSS OF CAPTURE, AND PACING INHIBITION. 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 24030791 ↗InjuryDec 15, 2025Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO FRACTURE CREATING NOISE AND CAUSING OVERSENSING, WHICH LED TO INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23804899 ↗InjuryDec 3, 2025Break; Over-Sensing; Ambient Noise Problem; Break; Over-Sensing; Ambient Noise Problem
T-WAVE OVERSENSING COUPLED WITH SOME EVENTS ON RECORDING THAT APPEAR TO BE LEAD NOISE WERE REPORTED. ADVISED TO BRING PATIENT IN FOR FULL FOLLOW UP WITH ISOMETRIC TESTING. OTHER TRENDS APPEAR NORMAL. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704659 ↗
Other Permanent defibrillator electrodes devices
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- 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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