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

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.

• 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 Key: 9277211
• MDR Text Key: 168079123
• Report Number: 3005099803-2019-05176
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0022387376
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention