AMS ACTICON NEOSPHINCTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-16 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).

Event Text Entries

[5873997] It was reported the patient had her acticon pump and balloon removed in (b)(6) 2006 due to infection. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5

[13369693] Additional information: balloon, catalog #: 72400024, expiration date: 8/11/2008, serial #: (b)(4), manufacture date: 8/2003. Pump, catalog #: 72402287, expiration date: 7/21/2009, serial #: (b)(4), manufacture date: 7/2004.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2183959-2015-00243
• MDR Report Key: 4847076
• Report Source: 05
• Date Received: 2015-06-16
• Date of Report: 2008-07-28
• Date Mfgr Received: 2015-06-05
• Date Added to Maude: 2015-06-16
• 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: 2015-06-16
• 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	2015-06-16