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Entovis SR-T 371994Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04035479115197), received between Sep 4, 2019 and Jan 19, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (3 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.

Most reported problems

Device problems

  • Battery Problem3
  • Premature Elective Replacement Indicator2
  • No Pacing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient2
  • Bradycardia1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 19, 2023No Pacing; No Pacing

    ON (B)(6) 2022 PATIENT COLLAPSED WHILE WORKING OUT, EMS CLAIMED PATIENT WAS BRADYCARDIC AND PATIENT WAS TAKEN TO ER WHERE THE PHYSICIAN DETERMINED THAT HE WAS NOT RECEIVING PACING. THE PACING LEAD IS A COMPETITORS LEAD. IT IS UNCLEAR WHETHER THIS IS A LEAD OR DEVICE ISSUE. PACEMAKER WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Patient problems: Bradycardia

    MAUDE report 16205017 ↗
  • MalfunctionApr 23, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

    AFTER AN IMPLANTATION PERIOD OF APPROX. 108 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE PACEMAKER WAS EXPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11713006 ↗
  • MalfunctionMar 26, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

    AFTER AN IMPLANTATION PERIOD OF APPROX. 86 MONTHS, IT WAS REPORTED THAT A BATTERY ERROR MESSAGE WAS OBSERVED ON INTERROGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11577588 ↗
  • MalfunctionJan 13, 2021Battery Problem; Battery Problem

    THIS DEVICE SHOWED A BATTERY ERROR UPON INTERROGATION. DEVICE ANALYSIS REVEALED A BATTERY ISSUE. DEVICE EXPLANTED. 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 11167759 ↗
  • MalfunctionApr 29, 2020Battery Problem; Battery Problem

    AFTER AN IMPLANTATION PERIOD OF APPROX. 73 MONTHS, A BATTERY ERROR MESSAGE WAS REPORTED DURING THE FOLLOW-UP FOR THE PLANNED EXCHANGE OF THE DEVICE. THE PACEMAKER WAS EXPLANTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10010598 ↗
  • MalfunctionSep 4, 2019Battery Problem; Battery Problem

    AFTER AN IMPLANTATION PERIOD OF APPROX. 81 MONTHS, IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED DURING INTERROGATION. A SUDDEN DECREASE IN THE ESTIMATED SERVICE TIME WAS NOTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8962638 ↗

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Sources and updates

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