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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
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MEDTRONIC MILACA, INC. CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS Back to Search Results
Model Number 29901
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
It was reported that the clinician received the error code during boot up.The clinician was advised to turn off the programmer and then back on and the issue was resolved.The programmer remains in use.There was no patient involvement.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
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Brand Name
CARELINK ENCORE
Type of Device
PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
Manufacturer (Section D)
MEDTRONIC MILACA, INC.
900 sixth avenue ne
milaca MN 56353 372
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4314749
MDR Text Key15355278
Report Number2183613-2014-01385
Device Sequence Number1
Product Code OSR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29901
Device Catalogue Number29901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2014
Date Device Manufactured08/13/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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