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	Incontinence (1928); Urinary Retention (2119); Dysuria (2684); No Code Available (3191)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, it was reported that the device was not used past expiry date.(b)(4).The complaint 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.
Event or Problem Description
Note: this pertains to the second of two devices implanted into the patient during two different procedures.It was reported to boston scientific corporation that a solyx blue sis system was implanted during a single incision sling procedure performed on (b)(6) 2019 for the treatment of stress urinary incontinence.According to the complainant, post procedure, the patient experienced more bladder leakage than she had before.On (b)(6) 2019, a mesh removal and placement of retropubic sling was performed by removing the solyx sling from the original surgery and was replaced with a lynx sling.There were no patient complications noted after the revision.On (b)(6) 2019, the patient returned to the physician because the patient developed incomplete bladder emptying with straining to void which required a self-catheterization.On the same day, the physician incised the lynx sling.During the patient's follow-up visit after the sling incision, the patient is reportedly still experiencing leaking more than before.Reportedly, the physician will be referring the patient to another physician.

• 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: 9689917
• Report Number: 3005099803-2020-00380
• Device Sequence Number: 3320042
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: 01/14/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR