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

Model Number M0068505000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Depression (2361); Dysuria (2684); Constipation (3274); Dyspareunia (4505)

Event Date 05/24/2011

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 obtryx was implanted on (b)(6) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; groin pain; anal pain; thigh pain; other pain: thigh pain runs down legs; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; psychiatric injury nonsurgical treatments: on (b)(6) 2011 the patient commenced pain medication: panadol osteo for the treatment of: pain.Treatment duration: 10 years.On (b)(6) 2021 the patient commenced psychological medication: loxalate 10mg for the treatment of: depression.Treatment duration: 8 months.On (b)(6) 2016 the patient commenced other medication (please specify): hiprex to prevent utis - was getting recurrent utis.Treatment duration: 5 years.On (b)(6) 2017 the patient commenced physiotherapy treatment.Treatment duration: 5 visits.On (b)(6) 2019 the patient commenced cortisone injections for the treatment of back pain.Treatment duration: 1 year - 2 injections.On (b)(6) 2021 the patient commenced pain medication: proxen; slow release pain medication.Treatment duration: 3 months.On (b)(6) 2011 the patient commenced pain medication: endone for when pain gets too bad.Treatment duration: 10 years on and off.

Event Description

It was reported to boston scientific corporation that an obtryx was implanted on (b)(6)2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; groin pain; anal pain; thigh pain; other pain: thigh pain runs down legs; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; psychiatric injury nonsurgical treatments: on (b)(6) 2011 the patient commenced pain medication: panadol osteo for the treatment of: pain.Treatment duration: 10 years.On february 1, 2021 the patient commenced psychological medication: loxalate 10mg for the treatment of: depression.Treatment duration: 8 months.On (b)(6) 2016 the patient commenced other medication (please specify): hiprex to prevent utis - was getting recurrent utis.Treatment duration: 5 years.On (b)(6) 2017 the patient commenced physiotherapy treatment.Treatment duration: 5 visits.On (b)(6) 2019 the patient commenced cortisone injections for the treatment of back pain.Treatment duration: 1 year - 2 injections.On (b)(6) 2021 the patient commenced pain medication: proxen; slow release pain medication.Treatment duration: 3 months.On (b)(6) 2011 the patient commenced pain medication: endone for when pain gets too bad.Treatment duration: 10 years on and off.***additional information received on august 3, 2022*** on (b)(6) 2014, the patient sought consult for lots of pain in suprapubic area since saturday night before.The patient was also experiencing nausea and some watery diarrhea.Upon examination, the patient felt tenderness in the abdomen suprapubically and complains of some end dysuria.In the physician's assessment, the patient also had infectious diarrhea.The physician diagnosed the patient to have moderate acute urinary tract infection.A stool - pcr multiplex and urinalysis were requested and the patient was prescribed with cephalexin 500mg 1 capsule four times a day.Urinalysis results noted positive leukocytes and small blood.On (b)(6) 2014, the patient was seen for follow up and she was slightly better but was still symptomatic for urinary tract infection.The patient was prescribed with norfloxacin 400mg 1 tablet twice a day.On (b)(6) 2015, the patient was experiencing pain in the knees, left wrist, sciatic nerve, lower back pain, and hip pain.Trigger finger both hands corrected.The patient's pain was 4 out of 10 generally higher in the mornings and then settles.The patient was prescribed with paracetamol usually 2 mane and more if required to manage pain.The patient was also advised to take brufen if required.The patient was also advised alternative therapies, fish oil 2 a day and magnesium supplements.On (b)(6) 2015, the patient had spotting which lasted for about two weeks.The patient had a loop for stress incontinence four years ago.A pap smear and ultrasound of the pelvis were requested.Moreover, the patient also complained of soreness on the vulva.The patient was advised to try to use betadine and to r/v quickly if the pain worsens.

Manufacturer Narrative

Block a1: (b)(4).Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of erosion.Patient code e2330 captures the reportable event of pain.Patient code e1310 captures the reportable event of urinary tract infection.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; 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.Block h11: blocks a1, d4, g1, h4, h6 and h10 have been updated based on the additional information received on august 3, 2022.Block h6 (updates based on the additional information received on august 3, 2022): patient code e1301 captures the reportable event of dysuria.Patient code e1002 captures the reportable event of abdominal pain.

• Brand Name: OBTRYX SYSTEM - HALO
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930738
• MDR Text Key: 286874675
• Report Number: 3005099803-2021-07380
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 08/30/2022

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 Date: 09/30/2013
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML0092901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG