MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ACTICON NEOSPHINCTER; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number 72402106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Erythema (1840); Fever (1858); Unspecified Infection (1930); Sepsis (2067); Abnormal Vaginal Discharge (2123); Chills (2191); Discomfort (2330)

Event Type  Injury  

Event Description

Same patient/device as: 2183959-2018-00037.It was reported that following the removal of the acticon artificial bowel sphincter cuff and pump components), the patient had the balloon component removed due to infection, sepsis, and a cutaneous abscess of the abdominal wall.The patient was admitted to the emergency department (ed) on (b)(6) 2017 due to "intra-abdominal abscess post-procedure", "sepsis", fever, infection, and complaints of lower abdominal pain, chills, discomfort, erythematous area right and inferior suprapubic region, and vaginal discharge.Purulent fluid was found surrounding the reservoir and associated tubing.All foreign material was removed, purulent discharge was removed, area was flushed, suctioned, and a wound vac was placed.The patient was also treated with iv antibiotics.

• Brand Name: AMS ACTICON NEOSPHINCTER
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7447976
• MDR Text Key: 106091958
• Report Number: 2183959-2018-00049
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2008
• Device Catalogue Number: 72402106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90