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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 Problem Device Difficult to Program or Calibrate (1496)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that after updating the programmer, difficulties were experienced when programming an implantable device during implant. The "lead implant date" and "device implant date" were noted to not turn blue after changing them and after pressing "program", they were noted to remain blank. It was noted that the implantable device had been successfully programmed with a programmer that had not yet been updated. The same issue was noted to have occurred on multiple instances with different tablets. Troubleshooting was performed and it was noted that the update had changed the behavior of native controls for the programmer. The programmer remains in use. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Product event summary: the behavior of the native controls (date picker, keyboard) has changed to where-in - one tap outside of the control is needed to close the control (date picker, keyboard) and another tap is needed to reflect the changed value. As such, for setting a date, if you tap outside the date picker twice, you see the changed value shown as 'pending'. 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 Key9634150
MDR Text Key176499145
Report Number3004593495-2020-00066
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
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
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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