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); Constipation (3274); Dyspareunia (4505)
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Event Date 01/01/2011 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (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) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; rect pain; thi pain; pain inter; diff bowel; incont not pres.Nonsurgical treatments: on (b)(6) 2010 the patient commenced other medication (please specify): vagifem for the treatment of: provide.Treatment duration: 11 years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: help treat incontience.Treatment duration: 12 months.On (b)(6) 2011 the patient commenced other (please specify).Treatment duration: 10 years.
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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), 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; rect pain; thi pain; pain inter; diff bowel; incont not pres.Nonsurgical treatments: on (b)(6), 2010 the patient commenced other medication (please specify): vagifem for the treatment of: provide.Treatment duration: 11 years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: help treat incontience.Treatment duration: 12 months.On (b)(6), 2011 the patient commenced other (please specify).Treatment duration: 10 years.
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Manufacturer Narrative
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Block a1: meshc-20210928-bc637c44 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 # 3005099803-2020-06718.
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