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1,032 catalysts · 1,000 device adverse event · 21 approval · 6 device 510k · 3 device pma · 2 grant
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1,032 catalysts · 1,000 device adverse event · 21 approval · 6 device 510k · 3 device pma · 2 grant
Adverse Event Without Identified Device or Use Problem
Insufficient Information
Migration
Over-Sensing; High Capture Threshold
Adverse Event Without Identified Device or Use Problem
Fracture
Complete Blockage
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Excess Flow or Over-Infusion
Adverse Event Without Identified Device or Use Problem
No Display/Image
Biocompatibility
Wireless Communication Problem
Patient Device Interaction Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Insufficient Information
Adverse Event Without Identified Device or Use Problem
No Display/Image; Power Problem
Detachment of Device or Device Component
Lack of Effect
Break; Improper or Incorrect Procedure or Method
Computer Software Problem
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Loss of Osseointegration
Insufficient Flow or Under Infusion
Failure to Capture; Device Dislodged or Dislocated
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Fracture
Failure to Osseointegrate
Patient Device Interaction Problem
Loosening of Implant Not Related to Bone-Ingrowth
Migration
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Migration
Activation Failure
Failure to Osseointegrate
Adverse Event Without Identified Device or Use Problem