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

Model Number M0068317080

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

Patient Problems Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 02/01/2012

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a uphold was implanted into the patient on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: low stomach nonsurgical treatments: the patient was treated with psychological medication: endep 20mg for the treatment of: to help sleep at night and relax.On (b)(6) 2012 the patient commenced other medication (please specify): vagifem pessary 10mcg for the treatment of: lubrication.On (b)(6) 2012 the patient commenced other for the treatment of: incontinence - 24/7.Treatment duration: 40940.

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 uphold was implanted into the patient on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: low stomach.Nonsurgical treatments: the patient was treated with psychological medication: endep 20mg for the treatment of: to help sleep at night and relax.On (b)(6) 2012 the patient commenced other medication (please specify): vagifem pessary 10mcg for the treatment of: lubrication.On (b)(6) 2012 the patient commenced other (please specify): incontinence pads for the treatment of: incontinence - 24/7.Treatment duration: starting (b)(6) 2012.---updated information july 13, 2022--- it was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during an uphold implant procedure performed on (b)(6) 2012 for incontinence.The patient experienced complications and nonsurgical treatment.Patient symptoms included pain during intercourse, difficult bowel movement, incontinence not present prior to implant, psychiatric injury and other pain (low stomach).The patient was reported to undergo psychological medication and was taking endep 20mg to help sleep at night and relax.She also needed to use incontinence pads for incontinence 24/7 and used vagifem pessary 10mcg for lubrication.

Manufacturer Narrative

Additional information: blocks b5 and d4: lot number.Correction: d6a (implant date was not captured in the previous report).Block b3 date of event: date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6) australia.Block h6: patient codes e2330 and e1405 capture the reportable events of pain and dyspareunia.Impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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): 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: 12928915
• MDR Text Key: 286568101
• Report Number: 3005099803-2021-06661
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081048
• 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: 08/09/2022

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 Expiration Date: 05/31/2014
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00000149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2011
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 82 KG