BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Disability (2371)
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Event Date 12/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; 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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Event Description
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It was reported to boston scientific corporation that a boston scientific advantage device was implanted into the patient during a procedure.According to the complainant, after the device insertion, the patient has suffered back, leg, groin and sciatic pain and is unable to sit or walk long distances.Subsequently, the patient has transcutaneous electrical nerve stimulation (tens) machine all the time and has been constantly taking opioids since (b)(6) 2013.Boston scientific has been unable to gather additional information regarding the event to date.
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Search Alerts/Recalls
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