Iperia 7 VR-T DX DF-1 ProMRI Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024

Total Reports

447

Reports (30d)

1

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Device Explanted Due to ERI Behavior

battery, additional information, device remains, remains implanted

3

reports

2

Device Explanted Due to EOS Status

battery, additional information, showed, detected, remains implanted

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access
Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.