• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Disability (2371); No Code Available (3191)
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative
Report source: other: health canada adverse incident report reference (b)(4); submitted to hc (health canada) by the patient.(b)(4).The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an advantage system was implanted during a tension-free vaginal tape (tvt) procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient began to experience virulent neuropathic pain and pudendal neuralgia.The symptoms before the removal were reported to the physician in (b)(6) 2019.Pain was described by the patient as stinging, burning and stabbing (knife-like pain).She had irritation, cramping, spasm, tightness, needle-like and electric shock-like feeling in the vagina.Subsequently, the patient also had hypersensitivity over pubis, vulva, clitoris and perineum.She also stated that mere sexual thoughts would hurt her and she can't imagine having intercourse.Sitting for the patient was painful, intolerable after a little while and it was more tolerable when she took neurontin but not more than 30 to 45 minutes at a time.However, she could still feel the pain in the pubis, perineum, clitoris and buttocks.Pain could be lessened when lying or when sitting on a toilet seat.Pain could gradually increase during the day and could be worst in the evenings.It was intolerable for the patient in the evenings before taking neurontin.Nevertheless, the pain was often delayed and stayed long after the source of aggravation was gone.The patient also felt electric shock-like and stabbing sensations in the top of her pubis sometimes.Before the patient took neurontin, she felt like having steel wool under her pubic skin all of the time and merely wearing underwear was painful for her.It was a disabling situation for the patient as she was self-employed and couldn't work since (b)(6).She couldn't walk for more than 10 minutes, stretch, exercise, do any physical effort, do grocery and wear jeans or pants, as she must wear sweatpants or yoga pants since the pressure on the pelvic area was painful.Reportedly, the patient must sleep on her back, stayed home and rest on her back several times a day.Lastly, the patient's symptoms limits all her activities and all aspects of her life.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANTAGE SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9277211
MDR Text Key168079123
Report Number3005099803-2019-05176
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729470274
UDI-Public08714729470274
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 11/05/2019
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? No
Device Operator Health Professional
Device Expiration Date07/16/2021
Device Model NumberM0068502000
Device Catalogue Number850-200
Device Lot Number0022387376
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/07/2019
Initial Date FDA Received11/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-