MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Stroke/CVA (1770); Therapeutic Effects, Unexpected (2099); Coma (2417); Weight Changes (2607)

Event Type  Injury  

Event Description

It was reported that the patient had not really had any problems with her device until these last two years.She had a stroke, was in a slight diabetic coma, had not tasted food in two years, lost over 100 pounds, and weighed less than 100 pounds at the time of the report.She did not know what was going on, but had been told the device was working.No intervention or patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Event Description

Additional information received reported that the patient had a loss of therapeutic effect after the first few years of implant.The patient had nausea, vomiting, and weight loss.She had been working with her healthcare provider and the device battery hadn't depleted since the device could still be programmed.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type: lead; product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 4356617
• MDR Text Key: 5198858
• Report Number: 3004209178-2014-24417
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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 Expiration Date: 07/14/2007
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2015
• Date Device Manufactured: 01/20/2006
• 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; Other