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 Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (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 into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: most discomfort was being the first surgery and correction surgery have not removed implant.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pelvic, back and hip pain.Treatment duration: as necessary.The patient was treated with other (please specify) for the treatment of: urinary symptoms.

Manufacturer Narrative

Block a1: (b)(4).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 # 3005099803-2020-06525.

Event Description

It was reported to boston scientific corporation that a pinnacle was implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: most discomfort was being the first surgery and correction surgery have not removed implant.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pelvic, back and hip pain.Treatment duration: as necessary.The patient was treated with other (please specify) for the treatment of: urinary symptoms.

• 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: 12931207
• MDR Text Key: 284021173
• Report Number: 3005099803-2021-07610
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 62 KG