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 Problems Fever (1858); Pain (1994)

Event Date 03/17/2010

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2010, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that an obtryx transobturator midurethral sling and a pinnacle anterior apical graft were implanted into the patient during a transobturator tape, anterior repair with apical fusion and cystoscopy procedure performed on (b)(6) 2010 for the treatment of third-degree cystocele, second-degree uterovaginal prolapse and stress urinary incontinence.On postop day 0, the patient was initially having some pain.On postop day 1, the pain improved, however, she did spike a fever at day 1 until day 2 with maximum temperature about 102 degrees fahrenheit.She was started on rocephin 1g daily.By postop day 2, she had been afebrile and was prepared for discharge home, at which time, she was ambulating on her own.Her pain was controlled.She was discharged home to continue her antibiotic bactrim ds for 14 days.

• 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: 15587736
• MDR Text Key: 301576978
• Report Number: 3005099803-2022-05726
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 09/16/2022
• 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): Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Female