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

Model Number M0068318170

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)

Event Date 07/26/2021

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 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.

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 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
• 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: 12928609
• MDR Text Key: 286506467
• Report Number: 3005099803-2021-06795
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• 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,Followup
• Report Date: 11/28/2022

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: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG