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); Anxiety (2328); Depression (2361); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 06/20/2011

Event Type  Injury  

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.

Event Description

It was reported to boston scientific corporation that a pinnacle was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; pelvic pain; painful intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury.Surgical interventions: on (b)(6) 2015 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: anterior vaginal repair and excise area mesh erosion.Nonsurgical treatments: on (b)(6) 2011 the patient commenced pain medication: ibuprofen/ panadol (panamax) for the treatment of: pelvic pain relief and for pain from bowel movements.Treatment duration: 10+ years.On (b)(6) 2021 the patient commenced psychological medication: sertraline (antidepressant) for the treatment of: anxiety and depression from fear of faecal or urinary incontinence.Treatment duration: less than 6 months.On january 1, 2016 the patient commenced other medication (please specify): gastrostop for the treatment of: faecal urgency, incontinence.Treatment duration: 5+ years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises, pop.Treatment duration: unknown.On (b)(6) 2019 the patient commenced topical treatment (including oestrogen cream): vagifem pessary for the treatment of: vaginal health.Treatment duration: 1-2 years.On (b)(6) 2011 the patient commenced other (please specify) for the treatment of: urinary and faecal incontinence.Treatment duration: 10+ years.On (b)(6) 2021 the patient commenced pain medication: meloxicam for the treatment of: nsaid pelvic pain relief and for pain from bowel movements.Treatment duration: less than 6 months.On (b)(6) 2021 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises, pop.Treatment duration: less than 6 months.

Manufacturer Narrative

Block a1: meshc-20211006-3e4ee7cc.Block d4, h4: 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.Block h10: 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06571.

Event Description

It was reported to boston scientific corporation that a pinnacle was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; pelvic pain; painful intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury surgical interventions: on (b)(6) 2015 the patient underwent further surgery regarding the pinnacle implant under general anesthesia for the following purpose: anterior vaginal repair and excise area mesh erosion.Nonsurgical treatments: on (b)(6) 2011 the patient commenced pain medication: ibuprofen/ panadol (panamax) for the treatment of: pelvic pain relief and for pain from bowel movements.Treatment duration: 10+ years.On (b)(6) 2021 the patient commenced psychological medication: sertraline (antidepressant) for the treatment of: anxiety and depression from fear of faecal or urinary incontinence.Treatment duration: less than 6 months.On (b)(6) 2016 the patient commenced other medication (please specify): gastrostop for the treatment of: faecal urgency, incontinence.Treatment duration: 5+ years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises, pop.Treatment duration: unknown.On (b)(6) 2019 the patient commenced topical treatment (including oestrogen cream): vagifem pessary for the treatment of: vaginal health.Treatment duration: 1-2 years.On (b)(6) 2011 the patient commenced other (please specify) for the treatment of: urinary and faecal incontinence.Treatment duration: 10+ years.On (b)(6) 2021 the patient commenced pain medication: meloxicam for the treatment of: nsaid pelvic pain relief and for pain from bowel movements.Treatment duration: less than 6 months.On (b)(6) 2021 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises, pop.Treatment duration: less than 6 months.

• 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: 12930047
• MDR Text Key: 286855822
• Report Number: 3005099803-2021-07205
• 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,Followup
• Report Date: 01/27/2022

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 Model Number: 831-705
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/27/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG