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); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 11/01/2013 |
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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Multiple boston scientific mesh devices were implanted into the same patient.This report pertains to the pinnacle lite.It was reported to boston scientific corporation that a pinnacle lite prolapse repair mesh and an advantage incontinence sling were implanted into the patient on (b)(6) 2013.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; groin pain; perineum pain; anal pain; rectal pain; other pain: nerve pain in vulva, clitoris, under pubic bone & coccyx area; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2020 the patient underwent further surgery under general anesthesia for the following purpose: full mesh removal - the three mesh implants aforesaid removed.On (b)(6) 2013 the patient underwent further surgery for the following purpose: unsure some minor procedure performed 6 weeks after initial implant.
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Manufacturer Narrative
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Block a1: meshc-20211103-e87575c6.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 # 3005099803-2021-01256.
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Event Description
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Note: multiple boston scientific mesh devices were implanted into the same patient.This report pertains to the pinnacle lite.It was reported to boston scientific corporation that a pinnacle lite prolapse repair mesh and an advantage incontinence sling were implanted into the patient on (b)(6) 2013.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; groin pain; perineum pain; anal pain; rectal pain; other pain: nerve pain in vulva, clitoris, under pubic bone & coccyx area; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2020 the patient underwent further surgery under general anesthesia for the following purpose: full mesh removal - the three mesh implants aforesaid removed.On (b)(6) 2013 the patient underwent further surgery for the following purpose: unsure some minor procedure performed 6 weeks after initial implant.
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