Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

Agency Publication Date: May 4, 2021

Affected Products

Product: Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.

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Product: Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.

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Product: Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore

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Product: CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87662

Status: Active

Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Manufactured In: United States

Units Affected: 4 products (575815 units; 333408 units; 37690 units; 16,311 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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