(b)(6) the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Note: this report pertains to the second of the two upsylon devices implanted into this patient.It was reported to boston scientific corporation that an upsylon y-mesh was implanted into the patient on (b)(6) 2004.A second upsylon y-mesh implant was implanted into the patient on (b)(6) 2018.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; psychiatric injury.Nonsurgical treatments: on (b)(6) 2005 the patient commenced pain medication: numerous for: pain relief.Treatment duration: on going.The patient was also treated with unspecified incontinence medication, psychological medication, other medication, physiotherapy treatment (including pelvic floor exercises or training), topical treatment (including oestrogen cream), and injections (not associated with surgical treatment).
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