Protego SD 60/16 399408Recalls & 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 SD permanent defibrillator lead sits under the skin and wires the heart to a defibrillator. The 43 reports mostly describe noise picked up on the lead that led to shocks delivered when none were needed, plus cracks or breaks in the lead itself and insulation damage, sometimes requiring the lead to be removed or capped. Reports mention 16 injuries and no deaths, with 27 malfunctions. 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
- 43
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04035479136093), received between Jul 19, 2018 and Mar 6, 2026 — classified as 16 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (22 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 Problem22
- Fracture12
- Inappropriate/Inadequate Shock/Stimulation10
- Adverse Event Without Identified Device or Use Problem4
- Over-Sensing4
- Impedance Problem3
- Defibrillation/Stimulation Problem1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Shock from Patient Lead(s)11
- No Known Impact Or Consequence To Patient9
- Unspecified Infection4
- Ventricular Fibrillation2
- Fall1
- Ventricular Tachycardia1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2026Fracture
THIS RV LEAD WAS EXPLANTED 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 24537794 ↗InjuryJan 22, 2026Ambient Noise Problem
THIS RV LEAD SHOWS NOISE WHICH LED TO INAPPROPRIATE THERAPIES. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24151440 ↗InjuryJan 12, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation
THIS LEAD WAS EXPLANTED DUE TO FRACTURE RESULTING IN INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24037087 ↗MalfunctionDec 11, 2025Fracture; Fracture
THIS LEAD WAS EXPLANTED DUE TO LEAD INSULATION BREACH AND 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 23779969 ↗MalfunctionMay 2, 2025Ambient Noise Problem; Ambient Noise Problem
NOISE SEEN ON RV LEAD IN HMSC RECORDINGS. NOISE WAS NOT ABLE TO BE REPRODUCED IN OFFICE. EVALUATION OF LEAD IS NEEDED AND XRAY WAS ORDERED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950045 ↗InjuryJan 17, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE RESULTING IN INAPPROPRIATE SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 21178826 ↗MalfunctionNov 20, 2024Fracture; Fracture
THIS LEAD WAS EXPLANTED DUE TO SUSPECTED 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 20733945 ↗MalfunctionAug 22, 2024Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO INTERMITTENT NOISE NOTED ON RV PACE SENSE. PATIENT REPORTED A FALL WITH POSSIBLE CLAVICLE FRACTURE/DISLOCATION ABOUT SIX WEEKS PRIOR TO OVERSENSING. NEW RV PACE SENSE LEAD ADDED TO LEFT SIDE AND TUNNELED TO EXISTING RIGHT SIDED SYSTEM AND DOWNGRADE TO CRT-P. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Fall
MAUDE report 20039170 ↗InjuryMay 2, 2024Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO FRACTURE AND NOISE CAUSING INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 19228445 ↗MalfunctionApr 30, 2024Impedance Problem; Impedance Problem
THIS LEAD WAS CAPPED DUE TO IMPEDANCE OUT OF RANGE. PATIENT DOWNGRADED TO A CRTP SYSTEM. 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 19217402 ↗InjuryApr 15, 2024Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE RESULTING IN INAPPROPRIATE THERAPY. THERE WAS NOISE WITH MOVING ARM ABOVE HEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 19111758 ↗MalfunctionApr 1, 2024Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE DETECTING VF. THRESHOLD AND IMPEDANCE NORMAL. 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 19015212 ↗MalfunctionFeb 15, 2024Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCE. 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 18710679 ↗MalfunctionDec 11, 2023Ambient Noise Problem; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE AFTER CAR ACCIDENT WITH SEATBELT ON. 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 18307394 ↗InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 18069762 ↗MalfunctionJun 21, 2023Ambient Noise Problem; Ambient 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 17169861 ↗MalfunctionJun 6, 2023Impedance Problem; Impedance Problem
HMSC WEBSITE SHOWS OUT OF RANGE SHOCK IMPEDANCE SINCE (B)(6) 2021. 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 17075207 ↗MalfunctionJul 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS RV LEAD WAS CAPPED AND REPLACED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14955951 ↗MalfunctionMay 24, 2022Ambient Noise Problem; Ambient Noise Problem
INTERMITTENT NOISE WAS REPORTED ON THE RV CHANNEL IN RECORDINGS TRANSMITTED TO HOME MONITORING. NO INAPPROPRIATE THERAPIES WERE REPORTED. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14492383 ↗MalfunctionMar 19, 2022Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE AND OVERSENSING. 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 13826251 ↗InjuryFeb 17, 2022Fracture; Inappropriate/Inadequate Shock/Stimulation; Fracture; Inappropriate/Inadequate Shock/Stimulation
THIS RV LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 13549492 ↗InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 13440388 ↗MalfunctionJun 2, 2021Fracture; Fracture
LEAD CAPPED DUE TO RV LEAD FRACTURE. 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 11925360 ↗MalfunctionMay 25, 2021Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD CAPPED DUE TO FRACTURE CAUSING NOISE. 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 11881997 ↗InjuryApr 9, 2021Failure to Deliver Shock/Stimulation; Low impedance; Failure to Deliver Shock/Stimulation; Low impedance
LEAD REMAINS IMPLANTED. REPRESENTATIVE REPORTED AN ABORTED SHOCK DURING A VF EPISODE DUE TO SHOCK IMPEDANCE LESS THAN 20 OHMS. LEAD TRENDS APPEARED STABLE. FULL LEAD EVALUATION IN OFFICE RECOMMENDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Ventricular Fibrillation
MAUDE report 11642550 ↗
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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