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	Erosion (1750); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with graft, cuff suspension with graft, and posterior repair procedure performed on (b)(6) 2017, for the treatment of recurrent prolapse with an estimated blood loss of 200 ml.On (b)(6) 2019, the patient underwent vaginal mesh excision and a cystoscopy procedure for the treatment of atrophic vaginitis and a sensation of pressure in the bladder area.Moreover, the patient presented with an extensive history of reconstructive pelvic floor surgery, who had complaints of pelvic pain and vaginal spotting in the setting of apical mesh exposure in the vagina and desired surgical management.She does have a history of chronic pain, including evidence of levator spasm on exam.She also reported that she experienced urinary urgency and bladder discomfort at times with a very full bladder.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2017, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states, phone number: (b)(6).The revision surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states.(b)(4).The complaint device is not expected to be returned for evaluation; 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.

• 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: 15094304
• Report Number: 3005099803-2022-04062
• Device Sequence Number: 5234239
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: 02/17/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000056826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• 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: 55 YR
• Patient Sex: Female