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

Model Number M0068503010

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Ecchymosis (1818); Fatigue (1849); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); Anxiety (2328); Depression (2361); Prolapse (2475); Hematuria (2558); Urinary Incontinence (4572)

Event Date 04/06/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a lynx blue system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient claimed to have suffered the following injuries as a result of the implantation: constant pain, pelvic pain, back pain, failed sling, blood infections, urinary tract infections.It was also reported that the patient experienced economic damages such as medical bills as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Blocks a1, b5 and e1 below have been updated based on the additional information received on april 11, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Assistant: dr (b)(6).(b)(6) hospital.(b)(6).Block h6: patient codes e2330, e1310 and e1906 capture the reportable events of constant pain, pelvic pain, back pain, pain and suffering, urinary tract infection and blood infections.Impact code f1204 captures the reportable events of physical impairment and permanent physical injuries.Block 11: block d4 catalog number has been corrected.

Event Description

It was reported to boston scientific corporation that a lynx blue system device was implanted into the patient during a robotic abdominal - sacral colpopexy + mesh lynx mid - urethral sling + cystoscopy procedure performed on (b)(6) 2019 for the treatment of pelvic floor prolapse (grade 2 cystocele, grade 2 rectocele) and stress incontinence.The procedure was completed with no complications reported.Patient was transferred to pacu (post-aesthesia care unit) in stable condition.As reported by the patient's attorney, the patient claimed to have suffered the following injuries as a result of the implantation: constant pain, pelvic pain, back pain, failed sling, blood infections, urinary tract infections.It was also reported that the patient experienced economic damages such as medical bills as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Blocks a4, b2, b3, b5, b7, e1 below and h6: patient codes and impact codes have been updated based on additional information received on june 21, 2023.Block b3 date of event: date of event was approximated to april 6, 2019, based on the information that the patient was readmitted due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Assistant: dr.(b)(6).(b)(6) hospital.(b)(6).Revision surgeon: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: imdrf patient codes e2006, e172001, e1309, e2330, e1002, e1310, e1906, e1901, e1302, e0505, e050601, e0506, and e1401 capture the reportable events of vaginal mesh exposure, pelvic abscess, pain, abdominal pain, hesistancy, uti, blood infections, polymicrobial infection, blood in urine, hematoma, abdominal wall ecchymosis, vaginal bleeding, vaginal discharge, and foul-smelling bloody fluid.Imdrf impact codes f1905, f1901, f1204, and f1202 capture the reportable events of 4cm of mesh removed, percutaneous drainage, permanent physical injury and physical impairment.

Event Description

It was reported to boston scientific corporation that a lynx blue system device was implanted into the patient during a robotic abdominal - sacral colpopexy + mesh lynx mid - urethral sling + cystoscopy procedure performed on (b)(6) 2019 for the treatment of pelvic floor prolapse (grade 2 cystocele, grade 2 rectocele) and stress incontinence.The procedure was completed with no complications reported.Patient was transferred to pacu (post-aesthesia care unit) in stable condition.As reported by the patient's attorney, the patient claimed to have suffered the following injuries as a result of the implantation: constant pain, pelvic pain, back pain, failed sling, blood infections, urinary tract infections.It was also reported that the patient experienced economic damages such as medical bills as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.---additional information received on june 21, 2023--- on (b)(6) 2021, patient presented with 3 years history of vaginal pain, discharge and presence of mesh following midurethral sling placement at the time of total abdominal hysterectomy with bilateral salpingo-oophorectomy and anterior scoliosis correction (tah, bso, asc).Prior urology notes suggest presence of vaginal mesh at apex.The patient planned to have the mesh removed.On (b)(6) , 2019 to (b)(6) 2019, she readmitted with a pelvic abscess.She had percutaneous drain placed into the abscess on april 6, 2019.Cultures from the abscess were negative.She received cefepime and metronidazole prior to her transfer from lehigh valley hospital.Discharge to home with flagyl for 7 days.Percutaneous drain to be removed on may 2, 2019.Patient has had persistent pelvic pain and began having chills.She was also complaining of extreme fatigue.She presented with these symptoms on (b)(6) 2019 where she underwent percutaneous drainage of the abscess.The fluid was described as foul-smelling bloody fluid.The patient has been on cefepime and metronidazole since admission and feels somewhat better, although she still requires percocet for pain.Physical exam reporated abdominal tenderness, diffused but significantly more in left lower quadrant).There was large abdominal wall ecchymosis.In an assessment, it was stated that the patient had infected hematoma and polymicrobial infection.In a follow up appointment on (b)(6) 2019, the patient reported that she felt a bulge in the vaginal area and was noted to have hesitancy and intermittency.On (b)(6) 2021, the patient underwent mesh removal surgery.The patient had a longstanding history of vaginal pressure, pain, vaginal bleeding and evidence of vaginal mesh exposure from prior reconstructive repair using vaginal mesh.The exposed 4cm vaginal mesh that had been freed from the underlying tissue was removed and the remaining mesh retracted into the pelvis.The patient was extubated, transported to the recovery room in stable condition.In a progress note, it was stated that the patient attempted to void but was unable to do so.Patient was straining stating she needed to have a bowel movement and was instructed not to strain on multiple occasions, but she continued to strain.Patient was discharged to home without the need to have significant post op void.She was encouraged to take colace and drink fluids.Post mesh removal, patient stated she had been experiencing active bleeding in her urethra and got worse.Patient also presented with postoperative problem and blood in urine.It was reported that the cause of vaginal bleeding was the vaginal cuff from the previous hysterectomy that had opened, and she was oozing from above that.It was believed that a cuff dehiscence albeit was far out from her surgery in 2012.

• Brand Name: LYNX BLUE 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: 15541125
• MDR Text Key: 301152680
• Report Number: 3005099803-2022-05589
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: M0068503010
• Device Catalogue Number: 850-301
• Device Lot Number: 0021223514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 04/11/2023; 06/21/2023
• Supplement Dates FDA Received: 05/08/2023; 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 85 KG