MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

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

Patient Problems Fatigue (1849); Pain (1994); Tissue Damage (2104); Dizziness (2194); Injury (2348); Depression (2361); Numbness (2415)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 (bsc aware date) as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device 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 a solyx single incision sling system was implanted during a procedure performed on an unknown date.According to the complainant, she has been sick and wanted the device to be removed.Reportedly, she has difficulty opening her legs, has lost weight as has had difficulty opening her mouth to eat.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

Block b3: date of event was approximated to august 1, 2018 (3 months after implantation procedure, (b)(6) 2018) as no specific event date was reported.Block e1: this was reported by the patient.The solyx device was implanted by dr.Melvin propis at boca raton hospital at 800 meadows road, boca raton, florida and will be removed by dr.Raz from california.Blocks f10 and h6: patient codes 1994 and 2104 capture the reportable events of pain and sores which caused the patient difficulties to open her mouth and to walk, requiring mesh removal.Block h10: the complaint device is not expected to 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.Block h11: blocks a1, b5, and f10 patient codes have been updated based on the additional information received.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system was implanted during a cyst removal procedure performed on (b)(6) 2018.According to the complainant, three months after the device implantation, the patient became very ill and was experiencing adverse symptoms including pain, chronic fatigue, weight loss, and skin sores all over the patient.Reportedly, the sores started on her leg and spread to one side of the patient's face, the whole right ear, right side of her mouth and on her lips which causes the patient to have difficulty in eating.The patient went back to her implanting physician but the physician did not give her assistance.Furthermore, the patient's feet are reportedly numb which causes her to have difficulties in walking.The patient is starting to have pains in her legs and experiences chronic dizziness.The patient goes to the hospital every month and is on medication.She wants to have the mesh removed.The patient went to california and is in consultation with a physician from california regarding mesh removal surgery.The patient is reportedly feeling depressed and may be suicidal.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8537278
• MDR Text Key: 142673744
• Report Number: 3005099803-2019-01975
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

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 Date: 03/11/2021
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021847335
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 08/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention