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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problem Inadequate User Interface (2958)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2019
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 user was unable to select the "70bpm" icon in the analyzer application of the programmer, prior to an implant. It was noted that this icon was located at the edge of the tablet's display. The programmer remains in use. There was no patient involvement.

 
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Brand NameCARELINK SMARTSYNC
Type of DeviceANALYZER, PACEMAKER GENERATOR FUNCTION
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer (Section G)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8609797
MDR Text Key145037132
Report Number3004593495-2019-00456
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24970A
Device Catalogue Number24970A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/02/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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