Protego TD 65/16 359076Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04035479100490), received between Jun 20, 2018 and Jun 8, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture4
High impedance4
Ambient Noise Problem3
Break3
Inappropriate/Inadequate Shock/Stimulation2
Adverse Event Without Identified Device or Use Problem1
Failure to Capture1
High Capture Threshold1

Patient problems

No Clinical Signs, Symptoms or Conditions5
No Known Impact Or Consequence To Patient5
Shock from Patient Lead(s)2
Endocarditis1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 25437274 ↗
InjuryMar 11, 2026Break
LEAD WAS CAPPED DUE TO BREAK. 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 24573314 ↗
MalfunctionSep 4, 2025Fracture; High impedance; Ambient Noise Problem; Fracture; High impedance; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO FRACTURE, IMPEDANCE >3000 AND NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965886 ↗
MalfunctionAug 15, 2024High impedance; High impedance
LEAD WAS CAPPED DUE TO IMPEDANCE >3000. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996534 ↗
MalfunctionJul 14, 2023Failure to Capture; High impedance; Failure to Capture; High impedance
LEAD WAS CAPPED DUE TO OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3000 OHMS) AND NON-CAPTURE AT MAXIMUM OUTPUT DURING INTERROGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17326918 ↗
InjuryOct 20, 2022Break; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Break; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD WAS CAPPED DUE TO NOISE CAUSING VF DETECTION AND INAPPROPRIATE SHOCKS. LONG TERM IMPEDANCE GRAPH ALSO SHOWS INSULATION ISSUES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 15642962 ↗
MalfunctionDec 22, 2020Fracture; High impedance; No Pacing; Fracture; High impedance; No Pacing
THIS RV LEAD WAS CAPPED DUE TO A FRACTURE. IMPEDANCES WERE INCREASING AND THERE WAS NO PACING PRESENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11055667 ↗
MalfunctionJun 15, 2020Fracture; Fracture
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 Known Impact Or Consequence To Patient
MAUDE report 10155361 ↗
InjuryJun 11, 2020Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
PATIENT CAME TO ER AFTER RECEIVING INAPPROPRIATE SHOCKS DUE TO NOISE ON THE RV LEAD. DETECTION WAS SWITCHED TO OFF.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10144733 ↗
MalfunctionSep 25, 2019Break; Break
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD 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 9118518 ↗
MalfunctionAug 26, 2019Fracture; Fracture
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO FRACTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8932774 ↗
MalfunctionOct 23, 2018Positioning Failure; Positioning Failure
DURING THE IMPLANT OF THIS RV LEAD IT GOT STUCK, AND IF THE PHYSICIAN WOULD HAVE TAKEN IT OUT, IT WOULD HAVE PULLED OUT THE LV LEAD WHICH WOULD NOT PROVIDE BACKUP PACING. THE PHYSICIAN DECIDED TO CAP THIS LEAD AND IMPLANT AN ACTIVE RV LEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7995511 ↗
MalfunctionJun 20, 2018High Capture Threshold; High Capture Threshold
THIS LEAD WAS CAPPED DUE TO HIGH THRESHOLDS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7619800 ↗

Device details

UDI-DI	`04035479100490`
Brand	Protego TD 65/16
Model	359076
Company	BIOTRONIK SE & Co. KG
Product code	NVY · Permanent defibrillator electrodes
Class	Class 3
FDA submission	P980023
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 3, 2024

Device type (GMDN): Endocardial defibrillation lead

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

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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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