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 Abdominal Pain (1685); Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994)

Event Date 02/24/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.The reported lot number 0mlb123001 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.(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 posterior pelvic floor repair kit device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, after the implantation, the patient has experienced chronic pelvic pain, lower left abdominal pain, groin pain, levator spasms, pudendal neuralgia and recurrent incontinence.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10711024
• MDR Text Key: 212306549
• Report Number: 3005099803-2020-04587
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other