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

Model Number 3116

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Diarrhea (1811); Fatigue (1849); Paresis (1998); Complaint, Ill-Defined (2331); Abdominal Cramps (2543); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The consumer and health care provider (hcp) reported that the patient had the implantable neurostimulator (ins) for quite some time and the ins had been turned off.The patient's hcp wanted to talk to a manufacturer representative and the patient wanted the ins removed.The ins was turned off because the patient was having seizure and stomach problems since 2009.The patient was having more different stomach problems and needed to have an mri of the brain.The hcp turned the device off because they thought it was causing the patient more problems.The ins was deactivated shortly after implant in 2005 as the patient was diagnosed with a seizure disorder and theoretic potential for the stimulator to induce seizures.The patient was somewhat depressed and was fatigued.The patient was not on antidepressant or anti-seizure medication.The patient saw their hcp on (b)(6) 2016 and reported diarrhea and weight loss.The weight loss began 1 year ago and the patient lost 100 lbs.The first 50 lbs.Were intentional weight loss, but the weight continued to drift downward and had not stabilized.The patient had chronic diarrhea and abdominal pain following eating.Abdominal discomfort following eating could be characterized as cramping in nature and severe.The patient had gastroparesis.The patient ent had persistent diarrhea despite taking imodium.The patient had a cholecystectomy in 1994.The patient had a ct scan of their chest, abdomen, and pelvis, but the results were not yet received.The patient's abdomen was soft without rigidity or guarding and was non-tender to palpitation.The patient's bowel sounds were normal, and no masses, bruits, or ascites were present.The indication for use for this patient was gastric stimulation.

• 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: 5463128
• MDR Text Key: 39118041
• Report Number: 3004209178-2016-03535
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2007
• 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: 02/03/2016
• Initial Date FDA Received: 02/26/2016
• Date Device Manufactured: 08/11/2005
• 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): Other