MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number 831-817

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

Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123)

Event Date 08/25/2014

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 uphold lite was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; other pain: utis - recurrent infections, feeling that never really empties; offensive vaginal discharge; incontinence not present before implant.Nonsurgical treatments: on (b)(6) 2014 the patient commenced pain medication: celebrex for the treatment of: pain - mainly for back (possible use prior to 2014 surgery but much worse since).Treatment duration: 7 years.On (b)(6) 2016 the patient commenced other medication (please specify): antibiotics (usually keflex) for the treatment of: utis.On (b)(6) 2014 the patient commenced physiotherapy treatment (including pelvic floor exercises or training).Treatment duration: 2 attendances.O n (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): canesten for the treatment of: utis.Treatment duration: on and off.On (b)(6) 2016 the patient commenced pain medication: panadol osteo for the treatment of: pain.Treatment duration: 4-5 years.On (b)(6) 2016 the patient commenced other medication (please specify): ural for the treatment of: utis.Treatment duration: 5 years - on and off when needed.

Manufacturer Narrative

Block a1: (b)(6).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 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06677.

Event Description

It was reported to boston scientific corporation that an uphold lite was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; other pain: utis - recurrent infections, feeling that never really empties; offensive vaginal discharge; incontinence not present before implant nonsurgical treatments: on (b)(6) 2014 the patient commenced pain medication: celebrex for the treatment of: pain - mainly for back (possible use prior to 2014 surgery but much worse since).Treatment duration: 7 years.On (b)(6) 2016 the patient commenced other medication (please specify): antibiotics (usually keflex) for the treatment of: utis.On (b)(6) 2014 the patient commenced physiotherapy treatment (including pelvic floor exercises or training).Treatment duration: 2 attendances.On (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): canesten for the treatment of: utis.Treatment duration: on and off.On (b)(6) 2016 the patient commenced pain medication: panadol osteo for the treatment of: pain.Treatment duration: 4-5 years.On (b)(6) 2016 the patient commenced other medication (please specify): ural for the treatment of: utis.Treatment duration: 5 years - on and off when needed.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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: 12929164
• MDR Text Key: 286345476
• Report Number: 3005099803-2021-06813
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 831-817
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 69 KG