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
UnknownProduct 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.