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

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an uphold vaginal support system was implanted during an anterior vaginal repair using uphold mesh, posterior vaginal repair and cystoscopy procedures performed on (b)(6) 2017.As reported by the patient's attorney, the patient experienced an unknown injury.The patient was scheduled by the physician for a follow-up and surgery on (b)(6) 2021.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Correction: this was previously reported under mfr report 3005099803-2021-07194.Any new event information will be sent under mfr report 3005099803-2021-07194.Block d4 (model, catalog number) has also been updated.Block b3 date of event: date of event was approximated to february 24, 2017, implant date, as no event date was reported.Block d4, h4: the reported lot number, 0000026974, does not match the reported device.The upn reported, m006831810, was invalid; however the correct upn was found to be m0068318170 based on the description of the device as an uphold lite.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6), md.(b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite vaginal support system was implanted during an anterior vaginal repair using uphold mesh, posterior vaginal repair and cystoscopy procedures performed on (b)(6) 2017.As reported by the patient's attorney, the patient experienced an unknown injury.The patient was scheduled by the physician for a follow-up and surgery on (b)(6) 2021.

• Brand Name: UPHOLD LITE
• Common Device Name: 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: 15086256
• Report Number: 3005099803-2022-03899
• Device Sequence Number: 4814336
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female