MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number UNK-P-SLING-MENS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 04/28/2021

Event Type  Injury  

Event Description

It was reported that the patient had a sling device in service.He underwent a surgical procedure to implant a new artificial urinary sphincter (aus) device due to unknown reasons.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported incontinence cannot be established as the product is not available for analysis.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that the patient experienced recurring incontinence with his sling device.The patient underwent a surgical procedure in which a new artificial urinary sphincter device was implanted.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11849045
• MDR Text Key: 251422120
• Report Number: 2124215-2021-14269
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR