Evia SR 359531Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479101336), received between Jun 17, 2019 and Oct 28, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (2 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
Device problems
- Premature Elective Replacement Indicator2
- Pacing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS WERE REPORTED. BASED ON THE ANALYSIS RESULTS, THIS EVENT IS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712669 ↗MalfunctionAug 17, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
BASED ON THE ANALYSIS, WE ARE REPORTING THIS COMPLAINT. DEVICE HAD 30 PERCENT BATTERY IN (B)(6) 2020 AND WAS AT ERI IN (B)(6) 2020. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12334221 ↗MalfunctionJun 17, 2019Pacing Problem; Pacing Problem
DURING THE FOLLOW UP IN (B)(6) 2019, THE PROGRAMMER SHOWED THAT THE PACING RATE WAS 0. PACING CAN BE SEEN ON DYNAMIC ELECTROCARDIOGRAMS. EVIA SR WAS EXPLANTED AND REPLACED. 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 8703440 ↗
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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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