MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC ENLITE SENSOR

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.

• Brand Name: MEDTRONIC ENLITE SENSOR
• Type of Device: MEDTRONIC ENLITE SENSOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6650000
• MDR Text Key: 78019962
• Report Number: MW5070471
• Device Sequence Number: 3
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 100