inforMED
MalfunctionQDA

APPLE WATCH

Received Dec 27, 2024 · Event occurred Dec 18, 2024

Report MW5164056 · MDR key 21038182

Device

Generic name

Electrocardiograph Software For Over-the-counter Use

Manufacturer

Apple Inc.

Patient

78 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

I OWN AN APPLE WATCH. I HAVE SINUS NODE DYSFUNCTION WITH FIRST DEGREE BLOCK, WENKEBACH AND OTHER SINUS NODE ARRYTHMIAS. THE APPLE WATCH EKG(ELECTROCARDIOGRAM) APP FREQUENTLY REPORTS ATRIAL FIBRILLATION WHEN IN FACT IT IS A SINUS RELATED ARRYTHMIA WITH NO EVIDENCE OF A FIB. I WOULD ESTIMATE THE APP IS WRONG ABOUT 80-90% OF TIME. I PERSONALLY REVIEW ALL OF THE REPORTS AT THE TIME OF RECORDING. SINCE THE APP SAYS I HAVE AN A FIB DENSITY OF 25-30%, AND 80-90% ARE INCORRECT THIS IS NO MINOR PROBLEM. I SUSPECT THE APP IS SIMPLY LOOKING AT QRS INTERVALS TO MAKE ITS DETERMINATIONS. AS NOTED: SINUS NODE DYSFUNCTION.