MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC

Model Number M0068317050

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Scarring (2061); Deformity/ Disfigurement (2360)

Event Type  Injury  

Event Description

As reported by the patient¿s attorney, a boston scientific device was implanted.According to the complainant, the patient experienced infections, extrusion, erosion, pelvic and vaginal pain, bowel problems, continued urinary problems, bleeding, vaginal scarring, disfigurement, dyspareunia, hernia and back pain.The patient also had mesh revision surgery.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3606800
• MDR Text Key: 4169751
• Report Number: 3005099803-2014-00851
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 0ML8100201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention