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U.S. Department of Health and Human Services

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

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Failure to Capture (1081); Display or Visual Feedback Problem (1184)
Patient Problem Bradycardia (1751)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during a normal device change out, the patient experienced 5-10 seconds of bradycardia with a low escape rhythm of 10 beats per minute. The physician placed the programmer cables on the lead and it was noticed that there was no capture from the programmer. The physician quickly attached the leads to the new device and all was noted to be ok. When trying to determine what the issues was, it was noted that the tablet screen appeared normal except for no ventricular pacing output display. The output on the programmer was attempted to be changed to something else and the screen changed but errors were displayed. The programmer remains in use. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Analysis of the logs was unable to confirm that the user connected to the analyzer on the date specified but the logs indicated that the analyzer was connected to on the previous day. The logs showed that there was poor signal strength during the time of use which was an issue that was had been previously documented for further investigation. Logs also showed that the user was switching the application background/foreground which cause a safety ping timeout as designed. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameCARELINK SMARTSYNC BASE
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9450383
MDR Text Key170235725
Report Number3004593495-2019-01285
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,Followup
Report Date 03/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
Is This An Adverse Event Report? Yes
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 Received02/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/23/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/11/2019 Patient Sequence Number: 1
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