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); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
|
Event Date 06/10/2011 |
Event Type
Injury
|
Event Description
|
Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the pinnacle.It was reported to boston scientific corporation that a pinnacle prolapse repair mesh was implanted into the patient on (b)(6) 2011.An advantage sling was also implanted into the patient on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; other pain: leg pain ; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric 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.
|
|
Search Alerts/Recalls
|
|
|