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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC ILR DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. MEDTRONIC ILR DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number MDT-ILR
Device Problems Failure to Interrogate (1332); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) was unable to be interrogated. It was reported that the event was likely due to empty battery, faster than expected. The icm remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameMEDTRONIC ILR
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8730010
MDR Text Key149070282
Report Number2182208-2019-01128
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDT-ILR
Device Catalogue NumberMDT-ILR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
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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