MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS PERIGEE SYSTEM WITH INTEPRO; SURGICAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Anoxia (1711); Cardiac Arrest (1762); Death (1802); Incontinence (1928); Sepsis (2067); Urinary Tract Infection (2120); Brain Injury (2219); Prolapse (2475)

Event Date 02/01/2012

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced mixed urinary incontinence, vaginal vault prolapse, recurrent mid urethral descent and incompetence of pubocervical tissue.The plaintiff underwent a revision surgery.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as anoxic brain injury secondary to cardiac arrest and sepsis secondary to urinary tract infection.Related to mfr # 2183959-2016-00018, 2183959-2016-00019, 2183959-2016-00021, 2183959-2016-00022.

• Brand Name: AMS PERIGEE SYSTEM WITH INTEPRO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5361188
• MDR Text Key: 35702474
• Report Number: 2183959-2016-00020
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2016
• 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
• Treatment: BILATERAL SALPINGO-OOPHORECTOMY
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 75