MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317150

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

Patient Problems Erosion (1750); Incontinence (1928); Injury (2348); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 01/31/2014

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.Bl this event was reported by the patient's legal representation.The device was implanted at: (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 pfr kit pinnacle lite posterior was implanted into the patient during a procedure performed on january 31, 2014.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.The patient was also implanted with a non-bsc device on (b)(6) 2014.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a pfr kit pinnacle lite posterior was implanted into the patient during a procedure performed on (b)(6) 2014.The patient was also implanted with a non-bsc device on (b)(6) 2014.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; psychiatric injury.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: panodol for the treatment of: bladder and back pain.Treatment duration: ongoing.On (b)(6) 2015 the patient commenced incontinence medication: incontinence pads for the treatment of: incontinence.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): oestrogen for the treatment of: vaginal dryness.Treatment duration: ongoing.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to january 31, 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted by: dr.(b)(6).(b)(6) hospital.Block h6: patient code e2006, e1405, e0206 and e2330 captures the reportable event of erosion, dyspareunia, unspecified mental, emotional or behavioural problem and pain.Impact codes f12 and f2303 captures the reportable event of serious injury/ illness/ impairment and medication required.Block h10: 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.Block h11: block e1: physician's information has been added.Block b5 has been updated.Block h6: patient and impact code are updated.

• Brand Name: PFR KIT PINNACLE LITE POSTERIOR
• 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: 11177296
• MDR Text Key: 227024613
• Report Number: 3005099803-2021-00042
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: M0068317150
• Device Catalogue Number: 831-715
• Device Lot Number: ML00000345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 75 KG