MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPARC SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number NO IDE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Neuropathy (1983); Ambulation Difficulties (2544); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 05/13/2021

Event Type  Injury  

Event Description

Issues w/ levoflaxin and cipro; last year infectious disease dr.Put me on levoflaxin for ongoing mesh/ uti infections.I've taken cipro over the years and seemed to be fine, but last jan.The 'reaction' that didn't get reported was while taking levoflaxin, felt like my shoulder was torn out of joint.Got the wrong type of mri, insur wouldn't pay for the proper type again so close.Saw ortho who said i had up to 5 years to have surgery if didn't correct.I didn't report bc thought dr.Would.However, this year, they put me in cipro again for same issue bc i am becoming resistant to all antibiotics ( has sepsis , pic lines , chronically infected despite having surgery to revise mesh ) on going now 10 plus years.Taking a huge toll on my health and mental stamina.This last round of cipro, caused me to feel 90.Creaky and stiff, tired, sore, day 11 my legs felt like lead, day 12 i woke up with severe neuropathy from my waist down, making it nearly impossible to walk.I have seen all kinds of dr.'s including an 8 hour stay at (b)(6) er in (b)(6) on my first day of family vacation, as it grew worse with sitting / travel.So much more to the story, but i was very surprised to learn from 3 of my dr.'s that it wasn't reported this year or last.I was told not to take anything else in that class of antibiotic, although the current next step is invanz (and it would be my 3 rd round in a year ) i chose that as the less of 2 evils.I remembered reading about pulled tendons but never neuropathy! this is a big deal !! as not an expected reaction to such a frequently prescribed drug.I don't remember seeing it as a warning on paperwork that came w/ drug from (b)(6).Had to research online.Was told to stop taking immediately and go to er, it took me a few days as i am a hairdresser and was trying to get out of town.Both of my regular dr.'s we're out of town and i felt the covering dr.'s we're being a little dramatic, so wanted to give it a few days.My uro's pa told me she had had patients have this reaction, would normally clear in 3-4 days, one stayed permanently.I am going on week 5, seen neuro, and concierge and pain management and physical therapist and new pa for insurance referral.Been bumped from dr.To dr.I am pissed.This has literally disabled me.I can't drive, work, do stairs, or my job for more than a few hours seated.I am slated for a new neuro and nerve testing which i don't want to do bc of high risk for infection and antibiotic resistance.Was told by my pain management not to do that.Now i'm in a quandary because it's my word against theirs, but i am an exercising, moving gal, not a sedate lifestyle, and that has been instantly taken away.Now issues with bowels, urine leaks, sexual function, walking, standing, falling, balance.Not okay.Needing to look into disability ( not my style) so angry and hurt and feeling betrayed by not even being made aware that this was a potential side effect.Endured hours of mri's blood tests, and ultrasound and more and bills coming.I have a sparc sling that has been revised but not entirely removed.Been having infections since it went in 19 years ago, culminating in huge health issues and antibiotics resistance to almost all drugs outside of iv now.Fda safety report id# (b)(4).

• Brand Name: SPARC SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12049779
• MDR Text Key: 258624812
• Report Number: MW5102034
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): Y
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NO IDE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 62