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Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.