MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS INVANCE MALE SLING SYSTEM; SCREW, FIXATION, BONE

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Incontinence (1928)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Catalog #: screw: 72355009 mesh: 72403284.Expiration date: screw: 02/06/2004 mesh: 03/12/2004.Serial #: screw: (b)(4) mesh: (b)(4).Screw: (b)(6) 2003 mesh: (b)(6) 2003.

Event Description

It was reported that the patient had an invance sling implanted on (b)(6) 2003.The patient experienced recurring incontinence after a bone screw broke off and was implanted with an alternative continence device on (b)(6) 2017.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Removing from: catalog #: mesh: 72403284, expiration date: mesh: 03/12/2004, serial #: mesh: (b)(4), removing from mesh: 03/2003, additional information added to concomitant medical product.

• Brand Name: AMS INVANCE MALE SLING SYSTEM
• Type of Device: SCREW, FIXATION, BONE
• 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: 7143210
• MDR Text Key: 95654501
• Report Number: 2183959-2017-00119
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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: 12/15/2017
• 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: 77 YR