MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX HALO MESH

Model Number UPN M0068505000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Incontinence (1928); Nerve Damage (1979); Pain (1994); Ambulation Difficulties (2544); Abdominal Distention (2601)

Event Date 04/21/2011

Event Type  Injury  

Event Description

(b)(6) 2011, i was implanted with the boston scientific obtryx halo ref #850500, (b)(4), lot 1ml 1010602, ex 2014.Immediately, i had cutting pain and difficulty walking and leaked with i walked.I went numerous times to the er.I had, and am still having, physical therapy to help me walk again.I have chronic pain, feeling like i am being ripped open from the inside out in my abdomen.I can no longer do sit ups or crunches.Yoga is painful to my abdomen.I have nerve damage from my abdomen down my left leg to my heel.My right leg is weak and i cannot lift my right leg when sitting down.My left leg feels like i just drag it around with me.Sitting is painful.I now have a limp.I am fatigued all the time and hurt all over.My abdomen is tender and distended.Groin pain on left side.I am now leaking more than before surgery.I went from an active athletic women who went to the gym for three hours a day, cardio, swimming.Weights, belly dancing, yoga, active, message therapist to a women who now struggles to walk and struggles to perform her career as a massage therapist.Some days i cannot walk.Some days i have to stay in bed.Many days i cannot work.I have ceased going to the gym as it causes too much pain and have to rest all the next day to recover.I have gained weight no matter what dietary choices i make due to inability to exercise properly.Sex is now painful and my ability to orgasm is lost.I no longer have a g spot and can no longer experience g spot orgasms.Sex is very important to my mental and physical health and the implant has changed me.I have desire but cannot orgasm and sex is painful to myself and my boyfriend.My bladder leaking is much worse than before the surgery.My bladder gushes now when i cough or sneeze instead of just a bit of dribble.I did not dribble when i coughed before the implant, i dribbled a bit when i sneezed.I didn't have to wear a pad and could even go without underwear.Now i must wear a pad and even pads don't hold the urine.I have left buttock pain and sitting in chair s cause pain down my left leg so that when i stand back up i can barely walk.My bladder spasms.

• Brand Name: OBTRYX HALO MESH
• Type of Device: OBTRYX HALO MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5403636
• MDR Text Key: 37342935
• Report Number: MW5059821
• Device Sequence Number: 1
• Product Code: FTL
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2016
• Device Model Number: UPN M0068505000
• Device Catalogue Number: 8505000
• Device Lot Number: 1ML 1010602
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 91