inforMED
InjuryIPF

SHARPER IMAGE ABDOMINAL STIMULATOR

Received May 27, 2025 · Event occurred May 5, 2025

Report MW5170824 · MDR key 22091230

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Unknown

Product problems

  • Inappropriate/Inadequate Shock/Stimulation

Patient

67 YR · Female

  • Shock from Patient Lead(s)
  • Shock from Patient Lead(s)

Narrative

Description of Event or Problem

THIS 67-YEAR-OLD WOMAN WITH A PREVIOUSLY IMPLANTED SUBCUTANEOUS ICD (BOSTON SCIENTIFIC, 2024 FOR HISTORY OF ARRHYTHMOGENIC RIGHT VENTRICULAR CARDIOMYOPATHY AND MULTIPLE EPISODES OF PASSING OUT) WAS SEATED, AT HOME, USING A PERSONALLY PURCHASED ABDOMINAL ELECTRICAL STIMULATOR (THAT APPEARS WAS NOT MARKETED LEGALLY WITH FDA CLEARANCE) AND RECEIVED A DEFIBRILLATOR SHOCK THAT WAS UNCOMFORTABLE BUT DID NOT HARM HER. SHE TURNED OFF THE ABDOMINAL STIMULATOR IMMEDIATELY.