AMS ACTICON NEOSPHINCTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-01-30 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).

Event Text Entries

[5396700] It was reported that the acticon bowel sphincter was removed due to recurring incontinence. Another acticon device was implanted. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5

[12899712] (b)(6).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2183959-2015-00053
• MDR Report Key: 4467900
• Report Source: 01,05
• Date Received: 2015-01-30
• Date of Report: 2015-01-12
• Date of Event: 2014-12-30
• Date Mfgr Received: 2015-01-12
• Date Added to Maude: 2015-01-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. SHARON ZURN
• Manufacturer Street: 10700 BREN ROAD W
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal: 55343
• Manufacturer Phone: 9529306000
• Manufacturer G1: AMERICAN MEDICAL SYSTEMS (MN)
• Manufacturer Street: 10700 BREN ROAD W
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal Code: 55343
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMS ACTICON NEOSPHINCTER
• Generic Name: IMPLANTED FECAL INCONTINENCE DEVICE
• Product Code: MIP
• Date Received: 2015-01-30
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS (MN)
• Manufacturer Address: 10700 BREN ROAD W MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2015-01-30