FDA-Device2022-08-17Class I
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Sold states
Worldwide Distribution
Affected count
1657 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2022Don't want to check this manually?
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