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

Model Number M0068503000

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Retention (2119); Hematuria (2558); Dysuria (2684)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The mesh excision surgeon is : dr.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted into the patient during a anterior/posterior colporrhaphy + lynx mid urethral sling placement procedure performed on (b)(6) 2015 for the treatment of symptomatic cystocele and rectocele, mixed incontinence (urge/stress).On (b)(6) 2015, the day after the implant, the patient experienced minimal vaginal bleeding and unable to urinate after the foley was removed.Urine retention was notified and the patient reports sharp pain at foley site and vaginal pressure.The patient was given percocet for pain.On (b)(6) 2019, the patient visited hospital due to gross hematuria, urethral erosion and hypertension.The patient began to notice gross hematuria and discomfort feeling with urination.Describes as scratchy.The patient had exam and cystoscopy revealing mesh migrating through urethra.The patient then underwent surgery for mesh excision and confirmed the presence of urethral erosion into the mid and proximal urethra.The mesh involved the lower half of the mid/proximal urethra, and this had to be resected in order to excise the mesh.A 6cm incision was made over the left labia.A 2cm x 6cm martius flap was dissected out.This was tunneled under the vaginal mucosa to the area of the urethral repair.There were no complications reported and the condition of the patient was reported to be stable.Consequently, the patient was advised to start taking medications of ciprofloxacin hci 500g, 1 tablet by mouth twice daily and ketorolac 10mg, 1 tablet by mouth every 6 hours as needed for up to 9 doses.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13005870
• MDR Text Key: 285089501
• Report Number: 3005099803-2021-06276
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: ML00001664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White