MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER BONE ANCHOR FOR SOFT TISSUE ATTACHMENT; STAPLE, FIXATION, BONE

Model Number M0068201110

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

Patient Problems Erosion (1750); Pain (1994); Deformity/ Disfigurement (2360)

Event Type  Injury  

Event Description

As reported by the patient¿s attorney, a vesica sling system (mfr report # 3005099803-2014-03114) and a protegen sling (mfr report # 3005099803-2014-03113) were implanted into the patient on (b)(6) 1997.According to the complainant, the patient experienced pelvic and vaginal pain, ongoing urge/stress incontinence, bowel problems, dyspareunia, extrusion of mesh, bleeding, recurrence requiring additional implant, revision surgery, back pain and disfigurement.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4096116
• MDR Text Key: 4703960
• Report Number: 3005099803-2014-03114
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068201110
• Device Catalogue Number: 820-111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention