Protego SD 65/18 399410Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 04035479136116), received between Mar 24, 2016 and Sep 15, 2026 — classified as 47 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (64 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Ambient Noise Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778911 ↗
• InjuryAug 6, 2026Fracture

  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 50164247 ↗
• MalfunctionJun 12, 2026Ambient Noise Problem

  RV PACE/SENSE CHANNEL SHOWS EVIDENT LEAD NOISE. FULL LEAD EVALUATION RECOMMENDED. LEAD 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 25487720 ↗
• InjuryJun 2, 2026Ambient Noise Problem

  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 25365983 ↗
• InjuryJun 1, 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 25354338 ↗
• InjuryJun 1, 2026Intermittent Capture; Unstable Capture Threshold

  THIS LEAD WAS CAPPED DUE TO INTERMITTENT LOSS OF CAPTURE AND VARYING THRESHOLDS UPON POSTURE CHANGES. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348969 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO BACTEREMIA INFECTION WITH SEPSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Bacteremia; Sepsis

  MAUDE report 25177589 ↗
• InjuryApr 29, 2026Break; Pacing Problem; Device Sensing Problem; High Capture Threshold

  THIS LEAD WAS ATTEMPTED TO BE EXPLANTED BUT BROKE WITH DISTAL PORTION OF LEAD REMAINING IMPLANTED. IN 2024, THE LEAD SIGNIFICANTLY INCREASED IN PACING THRESHOLD, DECREASED IN SENSING AND INCREASED IN PACING APPEARANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034046 ↗
• InjuryApr 23, 2026Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  RV LEAD NOISE, T-WAVE OVERSENSING, AND AN ACUTE INCREASE IN SHORT RV INTERVAL COUNTS BEGINNING APRIL 17, 2026 WERE REPORTED. ISOMETRIC AND POSTURAL MANEUVERS WERE UNABLE TO REPRODUCE THE NOISE OBSERVED IN STORED EPISODE RECORDINGS. LEAD PARAMETERS, INCLUDING SENSING, IMPEDANCE, AND CAPTURE THRESHOLDS, REMAIN STABLE AND WITHIN NORMAL LIMITS. THERE IS CONCERN FOR A POSSIBLE LEAD INTEGRITY ISSUE. THE LEAD 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; Shock from Patient Lead(s)

  MAUDE report 24971937 ↗
• MalfunctionApr 9, 2026Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO MULTIPLE EPISODES NOTED ON RECORDED EPISODES SHOWING NOISE ON ICD 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 24829931 ↗
• InjuryMar 26, 2026High impedance; Ambient Noise Problem

  EXTRACTED DUE TO NOISE AND HIGH IMPEDANCE. 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 24707073 ↗
• InjuryFeb 11, 2026Fracture

  THIS 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 24313236 ↗
• MalfunctionJan 26, 2026Impedance Problem

  HMSC REPORTED PACING IMPEDANCE < 200 OHM AND HV IMPEDANCE >150 OHM. NO NOISE OBSERVED DURING OFFICE CHECK ON (B)(6) 2026. FURTHER MEASUREMENTS OF SHOCK PATHWAY SHOWED RV > CAN IS NORMAL RANGE AND RV > SVC OUT OF RANGE. DATA TO BE PRESENTED TO PHYSICIAN FOR NEXT STEPS. LEAD CURRENTLY REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185375 ↗
• InjuryDec 9, 2025Adverse 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 23760880 ↗
• MalfunctionNov 24, 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 23630716 ↗
• InjuryOct 15, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; 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 23300783 ↗
• MalfunctionAug 11, 2025Fracture; Fracture

  THIS LEAD WAS EXPLANTED 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 22773258 ↗
• InjuryJul 30, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  THIS LEAD WAS EXPLANTED DUE TO NOISE, CAUSING INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22669289 ↗
• MalfunctionJul 21, 2025Ambient Noise Problem; Ambient Noise Problem

  THIS LEAD SHOWS NOISE. LEFT SIDE SYSTEM IS OOS, BUT 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 22560583 ↗
• MalfunctionJun 19, 2025Ambient Noise Problem; Device Sensing Problem; Impedance Problem; Ambient Noise Problem; Device Sensing Problem; Impedance Problem

  NOISE CAN BE SEEN CAUSING INAPPROPRIATE NST DETECTIONS. THE PACING IMPEDANCE HAS BEEN TRENDING <200 OHMS INTERMITTENTLY OVER THE LAST YEAR. THE SHORT RV INTERVAL COUNT HAS ALSO BEEN TRENDING >249 OVER THE LAST YEAR. THE PHYSICIAN AND PATIENT HAVE OPTED FOR NON-SURGICAL INTERVENTION AND DECIDED TO PROGRAM THE DEVICE TO BE LESS SENSITIVE. LEAD REMAINS IMPLANTED. NO ADVERSE EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290748 ↗
• InjuryMay 21, 2025Adverse 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 22064448 ↗
• InjuryFeb 13, 2025Fracture; Inappropriate/Inadequate Shock/Stimulation; Fracture; Inappropriate/Inadequate Shock/Stimulation

  THIS RV LEAD WAS CAPPED DUE TO FRACTURE RESULTING IN MULTIPLE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21374322 ↗
• MalfunctionJan 27, 2025Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem

  THIS LEAD WAS EXPLANTED DUE TO SUSPECTED FRACTURE CAUSING NOISE ON PACE/SENSE CHANNEL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249271 ↗
• MalfunctionJan 20, 2025Ambient Noise Problem; Ambient Noise Problem

  MONITORING REPORTED EPISODES SHOWING NOISE. LEAD TRENDS APPEAR STABLE. SUDDEN INCREASE IN SHORT INTERVALS SINCE AT LEAST (B)(6) 2024. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191489 ↗
• MalfunctionJan 2, 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 21052261 ↗