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 Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 03/04/2011

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold was implanted on (b)(6) 2011 and an advantage was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage; psychiatric injury nonsurgical treatments: the patient was treated with other medication (please specify): hrt.Treatment duration: few years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).The patient was treated with topical treatment (including oestrogen cream): ovestin cream.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.

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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06550.

Event Description

It was reported to boston scientific corporation that an uphold was implanted on (b)(6) 2011 and an advantage was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage; psychiatric injury.Nonsurgical treatments: the patient was treated with other medication (please specify): hrt.Treatment duration: few years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).The patient was treated with topical treatment (including oestrogen cream): ovestin cream.Device 1 of 2.

• 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: 12930791
• MDR Text Key: 286927575
• Report Number: 3005099803-2021-07562
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/27/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 50 KG