Protego T 65 379967Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Biotronik Protego T 65, a permanent lead (electrode) implanted in the heart to deliver defibrillation shocks for patients who need one. Most of the 30 reports describe the lead picking up signals or noise it shouldn't, sometimes triggering unwanted shocks or pacing, and also high or low electrical resistance, leads that moved out of position and had to be replaced, and broken insulation. Seven reports involved injuries and none involved death. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04035479121686), received between Oct 2, 2018 and May 13, 2026 — classified as 7 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing13
- High impedance6
- Inappropriate/Inadequate Shock/Stimulation5
- Ambient Noise Problem4
- Break2
- Failure to Capture2
- Low impedance2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient9
- Shock from Patient Lead(s)5
- Fall1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Signal Artifact/Noise
THIS LEAD WAS CAPPED DUE TO SIGNAL ARTIFACT. 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 25159917 ↗InjuryApr 6, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 80 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. THE PHYSICIANS DECIDED TO SWITCH OFF THE TACHY THERAPIES. THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 14029075 ↗MalfunctionMar 9, 2022Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 72 MONTHS IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO OVERSENSING IN THE VENTRICULAR CHANNEL LEADING TO ANTI-TACHYCARDIA PACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13704492 ↗MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
RIGHT VENTRICULAR LEAD DISLODGMENT. REVISION WAS PERFORMED, LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13282732 ↗MalfunctionDec 29, 2021Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROX. 52 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. A LEAD REVISION WILL BE DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13112556 ↗MalfunctionDec 22, 2021Over-Sensing; Low impedance; Over-Sensing; Low impedance
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 71 MONTHS IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO OVERSENSING AND LOW PACING IMPEDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13064094 ↗InjuryNov 15, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 68 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. THE PHYSICIAN DECIDED TO ADD NEW TACHY LEAD.
Patient problems: Shock from Patient Lead(s)
MAUDE report 12817418 ↗MalfunctionOct 8, 2021Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 71 MONTHS, IT WAS REPORTED THAT OVERSENSING IN THE VENTRICULAR CHANNEL WAS DETECTED. THE PHYSICIANS ARE EVALUATING FURTHER STEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12600591 ↗MalfunctionSep 27, 2021Ambient Noise Problem; Ambient Noise Problem
LEAD WAS EXTRACTED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533846 ↗MalfunctionAug 27, 2021High impedance; High impedance
LEAD EXPLANTED DUE TO HIGH RV PACING IMPEDANCE CURRENT MEASUREMENT AT >3000 OHMS. 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 12378785 ↗MalfunctionJan 28, 2021Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROX. 33 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEAD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11243505 ↗MalfunctionJan 4, 2021Break; Failure to Capture; Break; Failure to Capture
IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO LOSS OF CAPTURE AND A BREAK IN LEAD INSULATION. 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 11111129 ↗MalfunctionDec 12, 2020High impedance; High impedance
AFTER AN IMPLANTATION PERIOD OF APPROX. 27 MONTHS, IT WAS OBSERVED THAT THE IMPEDANCE OF THE RV LEAD IS TOO HIGH. BOTH LEADS LV AND RV LEAD WERE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10996485 ↗MalfunctionNov 20, 2020Ambient Noise Problem; Ambient Noise Problem
DURING THE REPLACEMENT OF THE GENERATOR, NOISE WAS OBSERVED. NOISE WAS STILL PRESENT AFTER GENERATOR CHANGE. WHEN CHANGED TO AAI SETTING, THERE WAS NO NOISE INTERRUPTION. SETTING WAS CHANGED TO THERAPY OFF. THE DOCTOR COMMENTED THAT THIS COULD BE SHOCK LEAD DAMAGE. LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10877886 ↗MalfunctionOct 26, 2020High impedance; High impedance
SOMETIME DURING 2018, THE RV PACING IMPEDANCE INCREASED FROM 600 TO 2000 OHMS. ALL OTHER PARAMETERS WERE NORMAL. THE SAME YEAR WE GAVE THE PATIENT HM AND CONTINUED TO FOLLOW VIA THE HMSC. A FEW WEEKS AGO, THE PACING IMPEDANCE SURPASSED 3000 OHMS AND THE PATIENT HAS BEEN INVITED FOR NEW RV LEAD IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10733561 ↗InjuryOct 1, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT APPROX. 66 MONTHS AFTER THE IMPLANTATION THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO VENTRICULAR OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. APART FROM THE SHOCKS NO FURTHER PATIENT SIDE EFFECTS WERE REPORTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10612318 ↗MalfunctionSep 30, 2020High impedance; High Capture Threshold; High impedance; High Capture Threshold
IT WAS REPORTED THAT APPROX. 45 MONTHS AFTER THE IMPLANTATION THE PACING THRESHOLD AND IMPEDANCE HAD AN INCREASING TREND. SENSING AND SHOCK IMPEDANCE WERE STABLE. FIBROSIS AT THE LEAD TIP WAS SUSPECTED. IT WAS DECIDED TO CAP THIS LEAD AND TO IMPLANT A NEW ONE. THE ICD WAS ALSO REPLACED DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10606216 ↗InjuryAug 26, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 33 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10454741 ↗MalfunctionAug 11, 2020Fracture; Fracture
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 Known Impact Or Consequence To Patient
MAUDE report 10393616 ↗MalfunctionJul 21, 2020Impedance Problem; Impedance Problem
STEADILY INCREASING PACING IMPEDANCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10303027 ↗MalfunctionJul 13, 2020Break; High impedance; Break; High impedance
IT WAS REPORTED THAT APPROX. 29 MONTHS AFTER THE IMPLANTATION THIS LEAD WAS EXPLANTED DUE TO SUSPICION OF A LEAD DAMAGE. THE LEAD IMPEDANCE MEASUREMENT WERE OUT OF RANGE (GREATER THAN 3000 OHMS).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10264018 ↗MalfunctionJun 26, 2020Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROX. 54 MONTHS, VENTRICULAR OVERSENSING WAS REPORTED. THE PATIENT WAS HOSPITALIZED FOR SCHEDULED LEAD REVISION. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10201232 ↗MalfunctionMar 20, 2020Ambient Noise Problem; Ambient Noise Problem
TWO ALERTS REGARDING NOISE ON THE RV CHANNEL WITH ABORTED SHOCKS WERE RECEIVED THROUGH HMSC. THE PATIENT REPORTED TO THE MD THAT HE HAD FALLEN DOWN A MONTH AGO WHILE HE WAS SKIING. A NEW RV LEAD WAS IMPLANTED ON (B)(6) 2020.
Patient problems: Fall
MAUDE report 9862701 ↗MalfunctionJan 30, 2020High impedance; High impedance
AFTER AN IMPLANTATION PERIOD OF APPROX. 50 MONTHS, IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS OUT OF RANGE: TOO HIGH. THE LEAD WAS CAPPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9649622 ↗MalfunctionJan 10, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT APPROX. 69 MONTHS AFTER THE IMPLANTATION, VENTRICULAR OVERSENSING WAS OBSERVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9577253 ↗
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- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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