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

Device Problem Defective Device (2588)

Patient Problems Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, as no event date was reported.However, the symptoms were present prior to the (b)(6) 2019 procedure.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon for (b)(6).(b)(4).

Event Description

Note: this report pertains to one of two devices used in the same patient.Refer to manufacturer report # 3005099803-2022-05521 for the associated device information.It was reported to boston scientific corporation that a lynx system was implanted on an unknown date.After the procedure, the patient experienced recurrent stress urinary incontinence secondary to hypermobility of the urethra.On (b)(6) 2019, the patient underwent another lynx sling implantation.During that procedure it was found that the previous lynx sling had slid behind the bladder neck, thus rendering it ineffective.As reported by the patient's attorney, the patient experienced an unknown injury related to the (b)(6) 2019 lynx sling.

• 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: 15473724
• MDR Text Key: 300559041
• Report Number: 3005099803-2022-05131
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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: 08/24/2022
• 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: 67 YR
• Patient Sex: Female