InjuryIPF
STIMULATOR, MUSCLE, POWERED
Received Sep 22, 2023
Report MW5146105 · MDR key 17809367
Device
Patient
41 YR · Male
- Electric Shock
- Electric Shock
Narrative
Description of Event or Problem
REGARDING BIOVENTUS BIONESS L300 (ELECTRONIC ORTHOSIS). THE QUALITY OF THE REPLACEMENT PADS FOR THIS DEVICE HAS DECLINED DRAMATICALLY. THE PADS ARE (B)(6) FOR A ONE YEAR SUPPLY, HOWEVER, THEY NOW DON'T LAST NEAR AS A LONG, AND HAVE TO BE REPLACED 3 TIMES AS FAST, INCREASING COSTS DRAMATICALLY. A ONE YEAR SUPPLY NOW LASTS ONLY 3-4 MONTHS. WE STARTED NOTICING THE FAST WEAR OUT OF THE PADS AS MY HUSBAND BEGAN EXPERIENCING SHOCKS FROM THE UNIT DUE TO THE QUICK WEAR DOWN.