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

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Discomfort (2330); Prolapse (2475); Dysuria (2684); Constipation (3274); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	03/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The provided patient age of 64 years is as of the time of device implantation.Date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.This event was reported by the patient's legal representation.The surgeon is: (b)(6).The following patient codes capture the reportable events below: (b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite vaginal support system was implanted into the patient during an anterior vaginal repair + uphold mesh, tvt exact retropubic sling + cystoscopy procedure performed on (b)(6) 2014 for the treatment of recurrent cystocele and stress incontinence.On (b)(6) 2015, the patient was seen for mesh surveillance.At that time, the patient reported she had been well, but over the last 6 to 8 weeks she intermittently felt some slight prolapse sensation and perhaps a slight incomplete emptying sensation in her bladder.She was a little constipated then.There has been no stress incontinence otherwise.During the day, she will only void 6-8 times, and once to twice overnight.Her urinary flow is generally good and does not stop starting; there is no consistent incomplete bladder emptying sensation.Bowel habits are somewhat irregular as per usual.Has no dyspareunia and has been using vagifem pessaries.A clinical examination found no significant prolapse apart from posterior vaginal wall laxity.There was no mesh exposure or tenderness.On (b)(6) 2017, the patient was seen for another mesh surveillance review.The patient had remained very well and was still happy with the results of surgery.She only occasionally experienced a prolapse sensation and had not noticed any recurrence of her stress urinary incontinence.She did still have some slight urinary urgency issues, leading to incontinence roughly once a week.Her urinary flow was a bit slower than before, but she could generally empty her bladder properly.Prior to this, she did try some oxytrol patches, which only provided marginal assistance to her overactive bladder issues.She did not have any bowel issues otherwise and had been diligently performing her pelvic floor exercises.Intercourse was only slightly uncomfortable afterwards, and she did not perceive this as being a problem.A clinical examination found the vaginal walls remained well supported.There was no evidence of mesh exposure or tenderness at all; pelvic muscle strength was graded 2/5.The patient was going to try five betmiga 25mg tablets for her urinary urgency issues.The doctor noted that the patient had completed her three-year mesh surveillance program with no problems and would only need to return if problems arose in the future.On (b)(6) 2018, the patient was seen for dysuria and (urinary) urge/frequency as well as suprapubic pain for a few days.Full ward test urine (fwtu) was positive for hemoglobin and leukocytes.The patient was diagnosed as having a urinary tract infection (uti) and was prescribed keflex capsules, 500 mg once per day.

• Brand Name: UPHOLD LITE
• Common Device Name: 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15392963
• Report Number: 3005099803-2022-05189
• Device Sequence Number: 17380335
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female