BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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It was reported to boston scientific corporation that a pinnacle implant and a upsylon y-mesh implant were implanted into the patient on (b)(6) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; pain inter; inab inter; rec incont; psych.Nonsurgical treatments: the patient was treated with topical treatment (including oestrogen cream): osteregean cream for the treatment of: painful sex.Treatment duration: 12 mths.
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Manufacturer Narrative
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Block h2: correction: block h6 (impact codes).Block a1: (b)(6).Block d4, h4: 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.Block h10: 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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Event Description
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Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the pinnacle.It was reported to boston scientific corporation that a pinnacle implant and a upsylon y-mesh implant were implanted into the patient on (b)(6) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; painful intercourse; inability to have intercourse; recurrent incontinence; psychiatric injury.Nonsurgical treatments: the patient was treated with topical treatment (including oestrogen cream): osteregean cream for the treatment of: painful sex.Treatment duration: 12 mths.
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