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

Model Number M0068504000

Device Problem Positioning Problem (3009)

Patient Problems Nerve Damage (1979); Pain (1994); Discomfort (2330); Depression (2361); Paresthesia (4421); Urinary Incontinence (4572)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a trans-obturator sling placement procedure.After the procedure, the patient has experienced intense and unbearable pain in the perineum, vagina, anus, and right buttock.She has also experienced pain when walking.The pains are described as burning, electric shocks, pinching, tingling, and so intense that sitting is nearly impossible without a special cushion.Her buttock pain was described as stabbing, pulling, and burning, radiating down into her right leg, left leg, right hip, and groin.Around (b)(6) 2021, her primary care physician diagnosed her with pudendal neuralgia.She had a scan and an mri, but the results showed nothing that could explain her pain.In (b)(6) 2022, she had a block infiltration test, which tested positive.She was recommended to have an operation for a transgluteal decompression of the pudendal nerve, but she sought out another surgeon who operates laparoscopically as she was very afraid of operations.Subsequently, on (b)(6) 2022, she had a 3d ultrasound, which showed that the mesh was located very close to the pubic ramus and was persistent with urethral hypermobility.Furthermore, she had an impression of having a foreign body inside her vagina or anus, such as heaviness.The patient has been on sick leave since june 2021, when her pain intensified but her exams were normal.The patient is having a hard time sitting down except with a special cushion; she can hardly drive or ride in a car except for very short trips; and it is impossible for her to do her job properly with children and babies.She has been on pain medication since september 2021 and has a follow-up appointment with a psychologist.The patient claims that her psychological and physical states have degraded progressively, and she is currently in a severe depression.She does perineal kinetics, balneotherapy, and has acupuncture and osteopathy sessions.She also has a follow-up appointment with a hypnotherapist who does ptr hypnosis.

Manufacturer Narrative

This event was reported by an anonymous user report to ansm (french competent authority) by the patient.The healthcare facility name and physician/healthcare provider information are unknown.The following patient codes capture the reportable events below: e2330 - pain.E0123 - pudendal neuralgia.E020202 - severe depression.The following impact codes capture the reportable events below: f1202 - impossible to do the job properly with children and babies.F2303 - block infiltration test.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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: 16535178
• MDR Text Key: 311206907
• Report Number: 3005099803-2023-01177
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0025987866
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female