MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317050

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

Patient Problem Insufficient Information (4580)

Event Date 10/16/2008

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit was implanted into the patient during a cystocele repair, extraperitoneal vaginal vault suspension, tension-free sling placement using a non-boston scientific tension-free vaginal tape (tvt), rectocele repair, and enterocele repair using bsc pinnacle mesh system anteriorly and the non-boston scientific mesh posteriorly procedures performed on (b)(6) 2008, for treatment of cystocele, uterovaginal prolapse, rectocele, stress incontinence, incomplete bladder emptying, urinary frequency, urinary urgency, dyspareunia, and constipation.There were no patient complications reported at the conclusion of the procedure.The patient's condition was reported to be stable when taken to the recovery room.As reported by the patient's attorney, the patient experienced an unspecified injury.

Manufacturer Narrative

Block b3: date of event was approximated to october 16, 2008, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• 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: 17390464
• MDR Text Key: 319751049
• Report Number: 3005099803-2023-04022
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 0ML8071402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female