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

Model Number M0068317100

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

Patient Problems Neuropathy (1983); Pain (1994); Injury (2348); Disability (2371); Sweating (2444)

Event Date 10/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; 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 pinnacle pelvic floor repair kits was implanted into the patient during a posterior repair with pinnacle mesh procedure performed on (b)(6) 2014 for the treatment of rectal prolapse and rectocele.As reported by the patient's attorney, the patient presented on (b)(6) 2014 with malabsorption, fatigue, and flu.She also had a significant lower abdominal pain, cyclical flushing, and sweating, and the physician was not certain if this was a reaction to the mesh.The patient has had a long standing pelvic pain since childbirth.Most of her pain was in the lumbo-sacral spine and some of the pain was in the sacro-iliac areas on both sides.She displayed ongoing signs of central sensitization and neuro-vascular pain, as well as musculo-skeletal triggers for her persistent pain, including pelvic girdle dysfunction and thoracic cage over activity in response to this.On (b)(6) 2017, the patient presented with severe post surgical neuropathy as a result of prolapse surgery involving mesh implant.The consequences of post surgical neuropathy include limiting the patient's ability to perform any physical activity other than the basic requirements of daily living.The required medication reduced her mental capacity to the point that she would not be able to maintain normal desk work duties.As a result, she is permanently disabled and not capable of maintaining any type of work schedule.

• 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: 11175553
• MDR Text Key: 227064403
• Report Number: 3005099803-2021-00036
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00001393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR