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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ENTERRA STIMULATION SYSTEM

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MEDTRONIC ENTERRA STIMULATION SYSTEM Back to Search Results
Model Number 3116
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Dehydration (1807); Headache (1880); Nausea (1970); Pain (1994); Weakness (2145); Lethargy (2560); Weight Changes (2607)
Event Date 12/09/2016
Event Type  Injury  
Event Description
I was transported from my primary doctor's office to emergency department because of weakness, nausea, lethargy, dehydration, stomach pain, headache.Had been trying to find a doctor to see about my medtronic gastric stimulation device since the doctor who implanted the device left his facility in march of 2015.For the past 2 weeks, my pre-implant symptoms have come back and are very strong making it difficult to eat, drink fluids, sleep, work or attend to my personal needs.In (b)(6) 2015, i called to re-schedule a routine f/u appointment with the surgeon who implanted the device and was told he had gone out on leave and they had just heard that he was not coming back.Because of that, there was no-one available to see his gastric stimulator pts.I was given the names of 3 doctors, 2 in (b)(6) (30 miles away) and 1 in (b)(6) (70 miles away) to try to see if they would accept me as a pt or i could call the device company to see what i should do.I called medtronic and they referred me to their website to see what physicians i might ask to accept me.It listed the 2 in (b)(6), 1 in (b)(6) and the doctor who had just left.I called back and told them that and was told that listing their names and keeping their info current on the medtronic website was purely voluntary on the physicians part.I called the practice in (b)(6) and was told they were not accepting any of dr (b)(6) pts.I have repeatedly called medtronic, my old physician's office and the (b)(6) md's to get someone to treat me.When my symptoms got so bad these past of weeks.I made those same calls and found that my old doctor's group still has no one trained and certified to care for people with this device.Medtronic referred me to their website and when i insisted on a different answer, told me a rep would call me.No one called.I called the (b)(6) group and was finally able to get an appointment for a tech to at least do a reading to see if the is even on.I was just so sick i kept calling and was told i had to see my doctor who implanted the device.I wasn't sure if the device was causing how sick i felt and couldn't get anyone who knew anything about the device to see or speak with me.I called my primary care doctor and got hysterical when they told me to see a gastroenterologist because i felt really sick and wanted to see if it was anything other than the device.They took me in friday afternoon and upon examination, my dr sent me to the emergency dept by ambulance.I had to keep talking everyone at the ed that they could not call the md on my device card and that they had to call medtronic if there was an emergency with the stimulator and to make sure they understood that they couldn't just call the practice my dr had been in and one of those surgeons could fill in.No one will take me as a pt.I work for (b)(6) medical center, the original surgeon worked for (b)(6) as did the emergency room md i saw friday.I was finally told by the (b)(6) practice that they did not take dr (b)(6) pts because there are a lot of us and they don't have the capacity.I have since found out that over 40 people had these devices implanted at (b)(6) while dr (b)(6) was here.I don't know what any of them are doing or who they might have gotten to accept them as pts.I go tomorrow for the reading and have no idea what to do if they say there's problem or it is not working.I don't understand how there can be no one to help me find someone to take over my care.It's a hud device.Substantial weight gain post device implant.Device is also perpendicular to body rather than horizontal.In close proximity to the original surgery, a suture tore free and caused the device to flip.
 
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Brand Name
ENTERRA STIMULATION SYSTEM
Type of Device
ENTERRA STIMULATION SYSTEM
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6185850
MDR Text Key62828270
Report NumberMW5066774
Device Sequence Number1
Product Code LNQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number3116
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
ALEVE; AMBIEN (PM); AMYTRIPLOLENE; CALCIUM ; COUGH DROPS OR THROAT DROPS; ENTERRA STIMULATION 3116 SYSTEM; LAMICTAL; MAXALT (PM); MULTI-VITAMIN; PAXIL; SEROQUEL (PM) ; VITAMIN D
Patient Outcome(s) Other;
Patient Age53 YR
Patient Weight136
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