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
Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 08/25/2014 |
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) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; incontinence not present before implant; psychiatric injury.Surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: removal of mesh.On (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: mesh removal.On an unspecified date the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: more mesh excised and removed.Nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: 2 morphine patches for: pain management.Treatment duration: ongoing.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): vagifem for: vaginal lubrication.Treatment duration: ongoing.The patient was treated with pain medication: targin for: pain management.Treatment duration: occasionally as necessary.On (b)(6) 2008 the patient commenced pain medication: panadol osteo for: pain management.Treatment duration: been a few years.
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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) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; incontinence not present before implant; psychiatric injury.Surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: removal of mesh.On (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: mesh removal.On an unspecified date the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: more mesh excised and removed.Nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: 2 morphine patches for: pain management.Treatment duration: ongoing.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): vagifem for: vaginal lubrication.Treatment duration: ongoing.The patient was treated with pain medication: targin for: pain management.Treatment duration: occasionally as necessary.On (b)(6) 2008 the patient commenced pain medication: panadol osteo for: pain management.Treatment duration: been a few years.
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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 # 3005099803-2021-00012.
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Event Description
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It was reported to boston scientific corporation that a pinnacle was implanted on march 15, 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; incontinence not present before implant; psychiatric injury.Surgical interventions: on (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: removal of mesh.On (b)(6) 2014 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: mesh removal.On an unspecified date the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: more mesh excised and removed.Nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: 2 morphine patches for: pain management.Treatment duration: ongoing.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): vagifem for: vaginal lubrication.Treatment duration: ongoing.The patient was treated with pain medication: targin for: pain management.Treatment duration: occasionally as necessary.On (b)(6) 2008 the patient commenced pain medication: panadol osteo for: pain management.Treatment duration: been a few years.
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