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

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

Patient Problems Erosion (1750); Diarrhea (1811); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Insufficient Information (4580)

Event Date 03/26/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx sling device was implanted into the patient during an implantation of a boston scientific pelvic sling procedure performed on (b)(6) 2015, to treat cystocele, stress urinary incontinence and rectocele.As reported by the patient's attorney, the implanted device caused the patient severe and permanent bodily injuries, significant mental and physical pain, and suffering.The implanted device failed to function as intended because it did not relieve the symptoms or otherwise alleviate the medical products they were intended to cure.Instead, the device caused the patient to suffer severe and debilitating pain, mesh erosion, exposure/extrusion/protrusion, infections, bleeding, dyspareunia, bladder problems and bowel problems, permanent disability, and other severe adverse health consequences after implant.She sought medical care from her physicians due to complications and problems.The patient incurred, and continues to incur, medical expenses to treat her injuries and condition.As a direct and proximate result of the device, patient also suffered, and continues to suffer, serious bodily injury and harm including revision surgery on (b)(6) 2021.She continues to receive medical treatment and is anticipated to undergo further surgeries to remove more mesh.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2015, implant date, 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.Block h6: imdrf patient codes e2006, e2330, e1906, e1405, e2401, e1311, e0506 and e0206 capture the reportable events of mesh erosion, pain, infections, dyspareunia, bladder problems, bleeding, mental pain and other severe adverse health consequences.Imdrf impact codes f1905, f1204 and f1202 capture the reportable events of revision surgery, permanent bodily injuries and permanent disability.

• Brand Name: LYNX SYSTEM
• 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: 17467581
• MDR Text Key: 320474953
• Report Number: 3005099803-2023-04171
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female