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

Model Number	M0068503010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported lot number 22769889 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.(b)(6).(b)(4).The patient indicated that the device is implanted and is not expected to be returned for evaluation; 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.The voluntary user medwatch number is mw5094347.
Event or Problem Description
It was reported to boston scientific corporation that a lynx blue sling was implanted during a cystocele and rectocele repair, and hysterectomy procedure performed on (b)(6) 2020 for the treatment of pelvic organ prolapse.According to the patient, immediately after the procedure, something was not right at her left pubic bone.The patient had suffered pain for a month with a level of 9 every time she would cough or sneeze, but that has gradually subsided.However, she still experiences pain.At the sixth week follow-up, it was discovered that the mesh eroded into the vagina.Since then, the patient has been going back to the doctors every six to eight weeks but is still unable to have intercourse.In addition to estrogen cream and pills, the patient has done three laser treatments and still has pain on the right side of the vagina.Reportedly, she can feel the sling at the point of pain at the top of the vagina and intercourse feels like a bottle of brush.Furthermore, the patient reports of experiencing bleeding.Subsequently, there is a possibility of undergoing another surgery to trim or remove the mesh.

• Brand Name: LYNX BLUE SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10141413
• Report Number: 3005099803-2020-02129
• Device Sequence Number: 2561132
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: M0068503010
• Device Catalogue Number: 73193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 60