Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
US Nationwide distribution in the state of North Carolina.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2021