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); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 05/10/2011

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 an uphold was implanted into the patient on (b)(6) 2011.Advantage fit was implanted into the patient on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; anal pain; rect pain; pain inter; diff bowel; rec incont; aggrav incont; damage; psych; oth pain: nerve and muscle pain in legs and feet another vaginal vault prolapse mesh (upsylon y-mesh) was subsequently implanted into this patient.Nonsurgical treatments: on (b)(6) 2011 the patient commenced pain medication: lyrica for the treatment of: to alleviate nerve and muscle pain.Treatment duration: over 10 years.On (b)(6) 2011 the patient commenced incontinence medication: oxytrol patches for the treatment of: to treat incontinence.Treatment duration: 3 months.On (b)(6), 2012 the patient commenced psychological medication: duloxetine for the treatment of: anxiety and depression.Treatment duration: 9 years.On (b)(6) 2012 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: for incontinence.Treatment duration: 8 years.On (b)(6) 2011 the patient commenced topical treatment (including oestrogen cream): vesicare for the treatment of: to treat incontinence.Treatment duration: couple of years.On (b)(6) 2011 the patient commenced pain medication: palexia for the treatment of: to alleviate general pain.Treatment duration: unsure.On (b)(6) 2011 the patient commenced pain medication: panadol for the treatment of: to alleviate general pain / muscular and nerve and skeletal pain.Treatment duration: over 10 years.On (b)(6) 2020 the patient commenced incontinence medication: betmiga for the treatment of: to treat incontinence.Treatment duration: 3 months.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: for incontinence.Treatment duration: 2 months.

• 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: 12929366
• MDR Text Key: 283087435
• Report Number: 3005099803-2021-06992
• 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
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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
• Date Manufacturer Received: 11/10/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 91 KG