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

Model Number 831-705

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

Patient Problems Erosion (1750); Pain (1994); Depression (2361); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 11/01/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle was implanted on (b)(6) 2016 and an obtryx ii was implanted on an unspecified date.The patient experienced complications, surgical and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; inability to have intercourse; recurrent incontinence; aggravated incontinence; psychiatric injury.Surgical interventions: on an unspecified date the patient underwent further surgery regarding the pinnacle implant for the following purpose: anterior and posterior repair with excision of mesh and sacrospinous hitch.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: opioids for: pain relief.On (b)(6) 2021 the patient commenced incontinence medication: ditropan for: urinary incontinence.On (b)(6) 2016 the patient commenced psychological medication: prozac for: depression.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).On (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): livial for: oestrogen tablets.The patient was treated with pain medication.Device 1 of 2.

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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.

• 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: 12930735
• MDR Text Key: 286929942
• Report Number: 3005099803-2021-07385
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 831-705
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 83 KG