MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX SYSTEM

Device Problem Difficult to Remove (1528)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 10/28/2009

Event Type  Injury  

Event Description

Implanted with boston scientific obtryx system for bladder incontinence.Was hospitalized in (b)(6) 2009 due to severe pain and bladder infection.In 2010 was taken to er due to bladder infection andpain.Dyspareunia and interstitial bladder developed.Doctor told me mesh could not be removed.Began bladder installations and test.Still have urinary incontinence.In (b)(6) 2011 had a medtronic device implanted to help control nerve damage and pain.Pain dsypareunia and bladder incontinence has not been improved.

• Brand Name: OBTRYX SYSTEM
• Type of Device: OBTRYX SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5849576
• MDR Text Key: 51361375
• Report Number: MW5063853
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 59 YR
• Patient Weight: 108