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 Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)

Event Date 02/22/2012

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 upsylon y-mesh was implanted on an unspecified date and a solyx was implanted on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; anal pain; rectal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury nonsurgical treatments: the patient was treated with pain medication: paracetamol for the treatment of: dull pain.Treatment duration: years.The patient was treated with psychological medication: effexor for the treatment of: depression.Treatment duration: years.The patient was treated with other medication (please specify).The patient was treated with topical treatment (including oestrogen cream): hiprex for the treatment of: prevent utis.Treatment duration: years.Device 2 of 2.

Manufacturer Narrative

Additional information: a1: patient identifier block b5 correction: d4: udi (populated) h6: impact codes (removed f12) block a1: meshc-20211001-d8c5cafb block b3 date of event: date of event was approximated to february 22, 2012, implant date, as no event date was reported.Block d4, h4: 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.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient code e2330 and e1405 capture the reportable events of pain and dyspareunia.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.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted on an unspecified date and a solyx was implanted on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; anal pain; rectal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury nonsurgical treatments: the patient was treated with pain medication: paracetamol for the treatment of: dull pain.Treatment duration: years.The patient was treated with psychological medication: effexor for the treatment of: depression.Treatment duration: years.The patient was treated with other medication (please specify).The patient was treated with topical treatment (including oestrogen cream): hiprex for the treatment of: prevent utis.Treatment duration: years.---additional information received on august 3, 2022--- this report pertains to one of three devices used during the same procedure, the solyx device.Refer to manufacturer reports # 3005099803-2021-07519 and 3005099803-2022-04890 for the associated device information.The patient was also implanted with an advantage fit system device on (b)(6), 2012.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930652
• MDR Text Key: 286870478
• Report Number: 3005099803-2021-07520
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• 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: 08/29/2022

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 Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 95 KG