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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
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PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS Back to Search Results
Model Number 29901
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2015
Event Type  malfunction  
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
Event Description
It was reported that the programmer battery was not working as the programmer lost power when unplugged.It was recommended that the battery be replaced.The status of the programmer is unknown.There was no patient involvement.
 
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Brand Name
CARELINK ENCORE
Type of Device
PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY  11900
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 Key5121161
MDR Text Key27527808
Report Number3004593495-2015-00292
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 company representative
Reporter Occupation Other
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number29901
Device Catalogue Number29901
Was Device Available for Evaluation? No
Date Manufacturer Received07/10/2015
Date Device Manufactured08/01/2014
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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