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); Abnormal Vaginal Discharge (2123); Constipation (3274); Insufficient Information (4580)
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Event Date 01/01/2015 |
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 was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; oth pain (stomach); off vag dis; diff bowel; rec incont; aggrav incont; damage.Surgical interventions: on (b)(6) 2015 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: repair.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pain.On (b)(6) 2015 the patient commenced incontinence medication: vesicare for the treatment of: incontinence - daily.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence - specific pelvic chair.The patient was treated with topical treatment (including oestrogen cream): ovestin cream.The patient was treated with other (please specify).
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Event Description
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It was reported to boston scientific corporation that a pinnacle was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; oth pain (stomach); off vag dis; diff bowel; rec incont; aggrav incont; damage.Surgical interventions: on (b)(6) 2015 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: repair.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pain.On (b)(6) 2015 the patient commenced incontinence medication: vesicare for the treatment of: incontinence - daily.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence - specific pelvic chair.The patient was treated with topical treatment (including oestrogen cream): ovestin cream.The patient was treated with other (please specify).
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Manufacturer Narrative
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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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06748.
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