BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE ANTERIOR / APICAL; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-714 |
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); Constipation (3274); Dyspareunia (4505)
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Event Date 10/24/2011 |
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 lite was implanted on (b)(6) 2011.The patient experienced complications, revision surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; thigh pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence surgical interventions: on an unspecified date the patient underwent further surgery for revision of the pinnacle lite mesh.Nonsurgical treatments: the patient was treated with physiotherapy treatment - chiropractor, once a month to assist with pain management.
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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 # 3005099803-2020-06764.
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Event Description
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It was reported to boston scientific corporation that a pinnacle lite was implanted on (b)(6) 2011.The patient experienced complications, revision surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; thigh pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence.Surgical interventions: on an unspecified date the patient underwent further surgery for revision of the pinnacle lite mesh.Nonsurgical treatments: the patient was treated with physiotherapy treatment - chiropractor, once a month to assist with pain management.
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Search Alerts/Recalls
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