(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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It was reported to boston scientific corporation that a solyx implant was implanted into the patient on (b)(6) 2017.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain, vaginal pain, pelvic pain, groin pain, perin pain, anal pain, rect pain, thi pain, off vag dis, diff bowel, rec incont, aggrav incont, damage, psych, oth pain: stomach.
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