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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC ENLITE SENSOR

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MEDTRONIC MEDTRONIC ENLITE SENSOR Back to Search Results
Device Problems False Reading From Device Non-Compliance (1228); Radio Signal Problem (1511); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 12/22/2016
Event Type  malfunction  
Event Description
Kept getting false readings, or change sensor, or lost signals. Never got more than 3 days out of one and they are supposed to last 6. They have replaced many of them and make me send bad one back for testing, never one time have they gotten back to me about what happened. I asked them to just refund my money, and i will send everything back. This is the second one of these i have had. The first one didn't work and when it was due for replacement i called and the lady guaranteed me all the bugs were worked out of the sensor now, so i ordered it. I used (2) of the new ones and it was just as bad as first one. It is all back in box in closed because it does not work and they say i have had it too long and won't take it back. If i had not of been guaranteed the bugs were all out, i sure wouldn't had reordered a new one. I even talked to the district rep in my area about it three weeks ago, and he was going to call me back and never did. His name was (b)(6) i think his area is (b)(6). I cannot believe the fda approved this junk. Please help! thanks.
 
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Brand NameMEDTRONIC ENLITE SENSOR
Type of DeviceMEDTRONIC ENLITE SENSOR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6650000
MDR Text Key78019962
Report NumberMW5070471
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2017
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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