BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Device Problem
Defective Device (2588)
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Patient Problems
Urinary Incontinence (4572); Insufficient Information (4580)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2018, as no event date was reported.However, the symptoms were present prior to the (b)(6) 2019 procedure.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon for (b)(6).(b)(4).
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Event Description
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Note: this report pertains to one of two devices used in the same patient.Refer to manufacturer report # 3005099803-2022-05521 for the associated device information.It was reported to boston scientific corporation that a lynx system was implanted on an unknown date.After the procedure, the patient experienced recurrent stress urinary incontinence secondary to hypermobility of the urethra.On (b)(6) 2019, the patient underwent another lynx sling implantation.During that procedure it was found that the previous lynx sling had slid behind the bladder neck, thus rendering it ineffective.As reported by the patient's attorney, the patient experienced an unknown injury related to the (b)(6) 2019 lynx sling.
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Search Alerts/Recalls
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