MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ADVANCE XP SLING SYSTEM; SURGICAL MESH

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Device was implanted in 2012.

Event Description

It was reported that the patient had his advance xp sling removed due to unspecified reasons.The advance xp was reported to have been originally implanted in 2012.An artificial urinary sphincter was implanted on a later date.It was noted "aus inserted to manage sui (stress urinary incontinence).No evidence of primary advance xp sling during aus implantation." no additional patient complications were reported in relation to this event.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7243366
• MDR Text Key: 99070541
• Report Number: 2183959-2018-00021
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR