Aurora EV-ICD™ MRI SureScan™
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Aurora EV-ICD™ MRI SureScan™ |
More than 10 numbers, contact manufacturer. |
DVEA3E4 |
Issue
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Through 2-October-2025, six (6) events (delay of 2-17 seconds) were observed among 4,900 implanted devices worldwide (~0.12%). Five of the six events experienced this behavior during a controlled defibrillation test. While not observed clinically, a delay in HV therapy may impact defibrillation efficacy.
Additional information
Details
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
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