MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number 850-411

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Headache (1880); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)

Event Date 01/31/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii sling was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; other pain: like getting stabbed with a hot poker in abdomen & thighs; 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) 2019 the patient underwent further surgery regarding the obtryx ii implant under general anesthesia for the following purpose: cystoscopy, laparoscopy & bilateral salpingectomy.- on (b)(6) 2021 the patient underwent further surgery regarding the obtryx ii implant under general anesthesia for the following purpose: excision of vaginal mesh, cystoscopy & eua.- on (b)(6) 2021 the patient underwent further surgery regarding the obtryx ii implant under general anesthesia for the following purpose: excision of vaginal mesh & cystoscopy.Nonsurgical treatments: - on (b)(6) 2016 the patient commenced pain medication: ovestin cream, anpec for cluster headaches due to stress, vesicare, escitalopram for anxiety, neo mercazole for overactive thyroid.For the treatment of: infections, cluster headaches, anxiety, incontinence, overactive thyroid.Treatment duration: 5.- on (b)(6) 2018 the patient commenced incontinence medication: vesicare 5mg for the treatment of: for incontinence.Treatment duration: 4.- the patient was treated with psychological medication.On (b)(6) 2017 the patient commenced other medication (please specify): escitalopram 20mg for the treatment of: anxiety & depression.Treatment duration: 4.- on (b)(6) 2019 the patient commenced topical treatment (including oestrogen cream): ovestin for the treatment of: continual disgusting discharge & to help with repair before & after surgeries.Treatment duration: 3.- the patient was treated with other (not specified).- on (b)(6) 2017 the patient commenced pain medication: panadin forte for the treatment of: abdominal pain & cluster headaches.Treatment duration: 4.

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.

• Brand Name: OBTRYX II SYSTEM - CURVED
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 12929723
• MDR Text Key: 286448233
• Report Number: 3005099803-2021-07149
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121754
• 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
• Report Date: 12/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 850-411
• Device Catalogue Number: 850-411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 64 KG