MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number 831-708

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 01/04/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold was implanted on (b)(6) 2020 and an advantage fit was implanted on (b)(6) 2021.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: neck pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; psychiatric injury.Nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: celaxib 100mg for the treatment of: back pain.On (b)(6) 2021 the patient commenced injections (not associated with surgical treatment): steroids injection for the treatment of: hip pain.Treatment duration: one dose.On (b)(6) 2021 the patient commenced pain medications: amitriptyline and osteomol 665 for the treatment of: back & hip pain.Treatment duration: indefinite.Device 1 of 2.

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 an uphold was implanted on (b)(6) 2020 and an advantage fit was implanted on (b)(6) 2021.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: neck pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; psychiatric injury nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: celaxib 100mg for the treatment of: back pain.On (b)(6) 2021 the patient commenced injections (not associated with surgical treatment): steroids injection for the treatment of: hip pain.Treatment duration: one dose.On (b)(6) 2021 the patient commenced pain medications: amitriptyline and osteomol 665 for the treatment of: back & hip pain.Treatment duration: indefinite.Device 1 of 2.

Manufacturer Narrative

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.Block h11: correction to block a2 (date of birth).

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930667
• MDR Text Key: 285352439
• Report Number: 3005099803-2021-07528
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 831-708
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 60 KG