MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE ANTERIOR / APICAL; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number 831-714

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); Insufficient Information (4580)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (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 implant was implanted into the patient on (b)(6) 2013 and a pinnacle lite implant was implanted into the patient on (b)(6)2013.The patient experienced complications, further surgery, and nonsurgical treatment.Device 2 of 2 patient symptoms include: yes back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; rec incont; aggrav incont; damage; psych.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: to treat recurrent prolapse and rolled up ball of mesh in the rectovaginal septum.

Event Description

It was reported to boston scientific corporation that a uphold implant was implanted into the patient on (b)(6) 2013 and a pinnacle lite implant was implanted into the patient on (b)(6)2013.The patient experienced complications, further surgery, and nonsurgical treatment.Device 2 of 2 patient symptoms include: yes back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; rec incont; aggrav incont; damage; psych.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: to treat recurrent prolapse and rolled up ball of mesh in the rectovaginal septum.

Manufacturer Narrative

Patient identifier: (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.

Manufacturer Narrative

Block a1: meshc-20211105-ffade002 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 # 3005099803-2020-06685.

Event Description

It was reported to boston scientific corporation that a uphold implant was implanted into the patient on (b)(6) 2013 and a pinnacle lite implant was implanted into the patient on (b)(6) 2013.The patient experienced complications, further surgery, and nonsurgical treatment.Device 2 of 2.Patient symptoms include: yes back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; rec incont; aggrav incont; damage; psych.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: to treat recurrent prolapse and rolled up ball of mesh in the rectovaginal septum.

• Brand Name: PFR KIT PINNACLE LITE ANTERIOR / APICAL
• 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; 952 brookside drive; spencer IN 47632
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12929202
• MDR Text Key: 286075351
• Report Number: 3005099803-2021-06895
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103426
• 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: 01/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 831-714
• Device Catalogue Number: 831-714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/28/2022
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 102 KG