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

Model Number M0068505110

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

Patient Problems Pain (1994); Anxiety (2328); Depression (2361); Dysuria (2684); Constipation (3274); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/11/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a procedure performed on (b)(6) 2018.Postoperatively, the patient claimed to have suffered pelvic pain, back pain, failed sling, urinary incontinence, bowel dysfunction, dysuria, and more to be determined in the course of discovery.She had also suffered pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury and more.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient codes e2330, e2401, e232401 and e1301 capture the reportable events of pelvic pain, back pain, pain and suffering, physical impairment, bowel dysfunction and dysuria.Imdrf impact code f1204 captures the reportable event of physical permanent injury.

• Brand Name: OBTRYX II SYSTEM - HALO
• 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: 17196282
• MDR Text Key: 317809296
• Report Number: 3005099803-2023-03291
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021581004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female