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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 Under-Sensing (1661); Battery Problem (2885); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that when the specialist went to use the analyzer, the patient connector had less than two percent battery remaining; it was noted that the base and connector had been fully plugged into the charger the day prior. The user also received a spinning wheel and the application locked up multiple times when attempting to enter the implant site. In addition, the connection to the device was lost during the case, and the user had to exit the application to reestablish connection. Troubleshooting steps were taken. However, when rechecking lead sensing measurements during a case the following day, the programmer failed multiple times, and the programmer lost telemetry, and r-waves were not able to be measured.

 
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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 Key9135106
MDR Text Key174948401
Report Number3004593495-2019-01006
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,Followup
Report Date 05/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2019
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 Received05/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/21/2018
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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