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); Incontinence (1928); Pain (1994); Perforation (2001); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion), back pain, vaginal pain, pelvic pain, groin pain, perineum pain, anal pain, rectal pain, thigh pain, other pain (pain when i cough or sneeze or if i get up to fast or if i stand for many hours at work ), painful intercourse, inability to have intercourse, offensive vaginal discharge, difficulties with bowel motions, incontinence not present before implant, recurrent incontinence, aggravated incontinence, damage, and psychiatric injury.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the uphold lite implant under general anesthesia for the following purpose: having pain and not being able to hold urine and always leaking.Nonsurgical treatments: on (b)(6) 2017 the patient commenced pain medication: nurofin, panadol, tramadol, for: pain relief.
Additional 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.
Additional Manufacturer Narrative
Blocks a1, b5, d4: lot number, expiration date an udi, d6: implant date, e1 (below) and g1: manufacturing site have been updated based on the ai received on november 2, 2022.Block a1: meshc-20210921-9d5bee3e.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the events below: e2006 - mesh erosion and exposure.E0206 - psychiatric injury.E2330 - pain.E1405 - painful intercourse.E2401 - "damage." e2114 - buttonholing during the implant.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite was implanted on february 7, 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; other pain (pain when i cough or sneeze or if i get up to fast or if i stand for many hours at work ); painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the uphold lite implant under general anesthesia for the following purpose: having pain and not being able to hold urine and always leaking.Nonsurgical treatments: on february 7, 2017 the patient commenced pain medication: nurofin, panadol, tramadol, for: pain relief.Additional information received on november 2, 2022: on (b)(6) 2017, the uphold lite with capio slim device was implanted as part of a procedure to address uterovaginal prolapse that included a bilateral salpingectomy, ap tvssf (anterior/posterior transvaginal sacrospinous ligament fixation), and cystoscopy.Additionally, the procedure was performed as a result of unsuccessful menorrhagia treatment.After placement of the uphold lite device, there was buttonholing noted in the right vault.The tissue behind the mesh was opened and mobilized, and the mesh was loosened and oversewn.On (b)(6) 2018, the patient underwent vaginal mesh excision due to dyspareunia and mesh erosion.Mesh exposure was visible in the right lateral vagina and was excised.Cystoscopy showed normal results; no visible mesh was noted on cystoscopy.

• 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: 12930694
• Report Number: 3005099803-2021-07191
• Device Sequence Number: 17350451
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 04/26/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000029299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/04/2021
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 80 KG