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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 Computer Software Problem (1112)
Patient Problem Cardiac Arrest (1762)
Event Date 10/31/2019
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 the implant procedure, the patient's device information was being entered into the programmer when the application froze, and became unresponsive. It was noted that the freeze occurred due to a known fault with special character use within the stored information. Shortly after this, the user was resetting the application and reconnecting the base unit when the patient went asystolic during lead placement. This had occurred when the analyzer was not available. Subsequently, external pacing had to be initiated and the patient's rhythm returned. The physician indicated that due to timing of the application error, the patient's life was at risk. The programmer remains in use. No further patient complications have been reported as a result of this event.

 
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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 Key9287033
MDR Text Key165318534
Report Number3004593495-2019-01174
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeMG
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
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2019
Is This An Adverse Event Report? Yes
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 Received11/25/2019
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

Patient TREATMENT DATA
Date Received: 11/06/2019 Patient Sequence Number: 1
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