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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_UKNOWN_INS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION NEU_UKNOWN_INS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bronchitis (1752); Dyspnea (1816); Fatigue (1849); Pain (1994); Scar Tissue (2060); Headache, Lumbar Puncture (2186); Malaise (2359); Sleep Dysfunction (2517); Weight Changes (2607)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information from the manufacturing representative (rep) reported that the healthcare provider (hcp) did an x-ray on the patient and they do not have a gastrointestinal stimulator in their body. It remains unclear which device the patient has implanted. Follow up is being conducted to clarify the information.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A patient reported they had been very sick, in and out of the er and urgent care lately and wanted a manufacturing representative (rep) to come teach them how to use the implantable neurostimulator (ins) that was recently implanted. They stated that the sooner they can reach an education goal, the more comfortable they will be. They did not sleep well at all and maybe that could change after the visit. Additional information from the patient reported they had spinal headaches, and had one at 5am on the morning of the report. They stated they have them off and on at the base of the nec additional information reported that the patient inquired about labeling of their device so they knew what type of doctor to search for. The patient stated that they had a shortness of breath and bronchitis (meds were not working). The patient also stated that they had a bronchoscopy completed (b/l infiltrates). It was also noted that their sleep had not been treated yet and was ordered remeron. Their issues of not sleeping well and being sick had not been resolved. The patient stated that it was still ongoing bronchitis like symptoms, they were exhausted, not sleeping well or hardly at all and they were adjusting their remeron to try to sleep. The patient had also experienced a lot of problems like spine pain/back pain and several bulged disks. They had gained a lot of weight with it and did not think it was working anymore. It was also reported that the patient had a scar in their lower abdomen like laparoscopic scar and one under their right ribcage, an inch and a half scar. When they did the surgery they took out a gallstone and their gall bladder. It was noted that the patient has not had any follow up care in years and their device needed to be explanted because it was not working. No further patient complications have been reported as a result of this event.
 
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Brand NameNEU_UKNOWN_INS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6517312
MDR Text Key101380558
Report Number3007566237-2017-01563
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN
Device Catalogue NumberNEU_UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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