BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number 831-705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Dyspareunia (4505)
|
Event Date 11/10/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported to boston scientific corporation that a pinnacle was implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; incontinence not present before implant; recurrent incontinence; aggravated incontinence.Nonsurgical treatments: the patient was treated with pain medication.The patient was treated with incontinence medication.The patient was treated with other medication (please specify).
|
|
Search Alerts/Recalls
|
|
|