MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Discomfort (2330); Complaint, Ill-Defined (2331); Depression (2361); Disability (2371); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 06/04/2001

Event Type  Injury  

Event Description

It was reported that the patient had severe extra abdominal pain/discomfort and distention several months after an elective surgery for a suspected colonic obstruction and adhesions in which part of her sigmoid colon was removed.It was noted that the patient did ¿wonderfully well after the surgery for several months,¿ until (b)(6) when she developed the aforementioned symptoms.There were no diagnostic procedures, surgery, hospitalization, or therapeutic actions taken.The patient reportedly felt that she resumed her daily activities too soon after surgery, and her bowel habits have also changed.The patient reportedly had an appointment to ¿be cleaned out¿ but was not able to despite three days of prep.It was noted that the patient was ¿really depressed¿ about it and was scheduled to undergo flexible sigmoidoscopy.It was stated that the patient¿s abdomen was ¿diffusely tender¿ and an incisional hernia was suspected by the healthcare provider.The event reportedly ended on (b)(6) 2001 as the patient recovered from event without therapeutic action, but then it was noted that the event continued.It was noted that there was permanent disability.Final outcome was not reported.Additional follow up is being conducted to obtain this information.A supplemental report will be sent if any additional information is received.

Manufacturer Narrative

Product id: 4351, serial# (b)(4), product type: lead.Product id: 4351, serial# (b)(4), product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4185503
• MDR Text Key: 5097531
• Report Number: 3007566237-2014-03038
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2001
• Initial Date FDA Received: 10/20/2014
• 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): Life Threatening; Required Intervention; Disability