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

Model Number M0068507001

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Depression (2361); Dyspareunia (4505); Insufficient Information (4580)

Event Date 06/15/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx was implanted on (b)(6) 2010.A second solyx implant procedure was performed on (b)(6) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; other pain: bearing down pain; painful intercourse; inability to have intercourse; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2009 the patient commenced psychological medication: pristiq sr 50 mg, anti-depressant to deal with unresolvable issues as a result of mesh/tape injuries and trauma.Treatment duration: 6.5 years.On (b)(6) 2010 the patient commenced other medication (please specify): hiprex, to inhibit bacterial growth in bladder.Treatment duration: 12 months.Device 1 of 2.

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 a solyx was implanted on (b)(6) 2010.A second solyx implant procedure was performed on (b)(6) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; other pain: bearing down pain; painful intercourse; inability to have intercourse; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2009 the patient commenced psychological medication: pristiq sr 50 mg, anti-depressant to deal with unresolvable issues as a result of mesh/tape injuries and trauma.Treatment duration: 6.5 years.On (b)(6) 2010 the patient commenced other medication (please specify): hiprex, to inhibit bacterial growth in bladder.Treatment duration: 12 months.Device 1 of 2 ***additional information received on july 20, 2022/correction: note: this manufacturer report pertains to the first of two devices implanted into the patient.A solyx was implanted into the patient during an anterior vaginal repair and cystoscopy procedure performed on (b)(6) 2010.A second solyx device was implanted into the patient during a vaginal sacrocolpopexy, cystoscopy, insertion of suprapubic catheter procedure performed on (b)(6) 2010.

Manufacturer Narrative

Additional information: block a3 block b5: procedure names for the second solyx implant.Blocks d4 and h4 correction to: blocks a1: patient identifier and b7 have been added.Block e1 (below) block a1: meshc-20210921-cd5cdca8 block b3 date of event: date of event was approximated to (b)(6) 2010, second solyx implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Additional attorney for the patient: rebecca jancauskas shine lawyers level 6, (b)(6).Block h6: the following patient codes capture the reportable events below: e2006 - erosion/extrusion e1405 - dyspareunia e2401 - "damage" e2330 - pain impact code f12 has been used in the light of the patient had filed a legal claim for an unspecified personal injury related to the device.Impact codes f1905 and f2303 capture the reportable events of device revision and medications.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.

• 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
• 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: 12930692
• MDR Text Key: 286866253
• Report Number: 3005099803-2021-07244
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081275
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 0ML9102801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2009
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 79 KG