Generic Name: Implantable Cardioverter-defibrillator — Brand Name: Aurora Ev Icd Mri Device
Summary Certain Aurora EV ICD MRI implantable heart devices may have a delay in delivering high-voltage therapy to treat abnormal heart rhythms in rare cases. The issue occurs because of how the device's sensing function temporarily pauses during charging, which can cause it to miss the heart's electrical signal and postpone treatment. Medtronic is addressing this problem through a software update delivered to patients' devices via a wireless programmer.
- Recalling firm
- Name of Manufacturer and Distributor: Medtronic Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
- Product
- Lot: モデル番号：DVEA3E4 改修対象製造番号： EVX603263S, EVX603264S, EVX603265S, EVX603266S, EVX603267S, EVX603529S, EVX603530S, EVX603531S, EVX603532S, EVX603533S, EVX603535S, EVX603536S, EVX603537S, EVX603539S, EVX603540S, EVX603541S, EVX603542S, EVX603546S, EVX603547S, EVX603548S, EVX603549S, EVX603550S, EVX603551S, EVX603552S, EVX603553S, EVX604001S, EVX604030S, EVX604031S, EVX604036S, EVX604044S, EVX604046S, EVX604049S, EVX604051S, EVX604053S, EVX604056S, EVX604060S, EVX604062S, EVX604069S, EVX604070S, EVX604071S, EVX604075S, EVX604078S, EVX604086S, EVX604453S, EVX604519S, EVX604533S, EVX604536S,...
- Reason
- We have received notification from the overseas manufacturer that, in rare cases, there may be a delay in initiating high-voltage therapy for tachyarrhythmias with the affected product. The cause of this issue is related to the temporary suspension of the automatic sensing adjustment function when high-voltage charging is completed during the processing of a sensed event. In this situation, the threshold is fixed at 53% of the R-wave amplitude from the previous beat; therefore, if the R-wave synchronized with high-voltage therapy falls below this fixed threshold, undersensing occurs, which...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/64c62291-b1d9-458a-822e-d9813d6a88ce