It was reported to boston scientific corporation that an obtryx system - curved device was implanted during a procedure performed on (b)(6) 2016.It was noted that the pain was felt in the abdomen, genitals, groin, lower back, perineum, and thighs.Additionally, symptoms of burning sensation, sleep problems, fatigue, loss of balance, muscle weakness, pollakiuria, urinary and fecal leakages, constipation, and prolapse were reported.It was indicated that the patient presented difficulties during prolonged walking, prolonged sitting, and during certain movements such as practicing sports, or during intimate relationships.Therefore, the patient noted their daily life had been compromised.It was detailed that an explant date was performed on may 05, 2021.Boston scientific has been unable to obtain additional information regarding the device location and patient outcome to date.
|