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	Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported to boston scientific corporation that a uphold lite implant and a obtryx ii implant were implanted into the patient on (b)(6) 2018.The patient experienced complications and further surgery.Patient symptoms include: eep; vaginal pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the obtryx ii implant under general anesthesia for the following purpose: removal of eroded mesh and botox put into my bladder to help with incontinence.
Additional Manufacturer Narrative
Block a1: (b)(6).Block b3: date of event is approximated to (b)(6) 2021, where patient underwent further surgery for the purpose of removing eroded mesh, as no event date was reported.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 e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(6) hospital.Block h6: the patient codes e1405, e1401 and e2330 represents the reportable event of dyspareunia, abnormal vaginal discharge, and pain.The patient impact code f12 represents patient seeking legal recourse for an unspecified personal injury related to the device.
Event or Problem Description
Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2021-06803 for the associated device information.It was reported to boston scientific corporation that a uphold lite implant and a obtryx ii implant were implanted into the patient on (b)(6) 2018.The patient experienced complications and further surgery.Patient symptoms include: eep; vaginal pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the obtryx ii implant under general anesthesia for the following purpose: removal of eroded mesh and botox put into my bladder to help with incontinence.Additional information as of 02nov2022: the procedure performed on, (b)(6) 2018, was anterior and posterior vaginal wall repair, sacrospinous fixation, mid-urethral sling procedure.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12928609
• Report Number: 3005099803-2021-06795
• Device Sequence Number: 4906080
• 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: 2018
• 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): 11/28/2022

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 Model Number: M0068318170
• Device Catalogue Number: 831-817
• 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: 12/03/2021
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG