Ilesto 5 DR-T 383566Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035479125226), received between Jan 12, 2021 and Jan 12, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Interrogate” (1 report).
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
- Failure to Interrogate1
Patient problems
- Syncope/Fainting1
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2021Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AFTER LOSING CONSCIOUSNESS. EXTERNAL CARDIOVERSION WAS ATTEMPTED AND PATIENT RECOVERED. AFTER PATIENT WAS STABILIZED, DEVICE INTERROGATION WAS ATTEMPTED, BUT THE DEVICE COULD NOT BE INTERROGATED. HOMEMONITORING DATA SHOWED THE DEVICE WAS APPROXIMATELY 30 PERCENT BEFORE EVENT, SO IT WAS ASSUMED THAT THE BATTERY WAS DEPLETED. ON (B)(6) 2020 THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Syncope/Fainting; Ventricular Fibrillation
MAUDE report 11156909 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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