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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Device Sensing Problem (2917); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during implant the right atrial (ra) lead exhibited oversensing/noise. The lead was re-positioned and the readings were good. No patient complications have been reported as a result of this event. 2020-02-07 it was reported that during device implant, the user was unable to visualize any electrical signals through the programmers atrial electrograms (egm) upon lead connection to the testing cables due to excessive noise. It was noted that the user pressed the "filter normalisation" button, but that it did not make any difference to the level of noise observed. When the testing cables were connected to a different programmer, both atrial and far field ventricular signals were able to be visualized. 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

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

 
Event Description

It was reported that during device implant, the user was unable to visualize any electrical signals through the programmers atrial electrograms (egm) upon lead connection to the testing cables due to excessive noise. It was noted that the user pressed the "filter normalisation" button, but that it did not make any difference to the level of noise observed. When the testing cables were connected to a different programmer, both atrial and far field ventricular signals were able to be visualized. 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.

 
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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 Key9681359
MDR Text Key178195837
Report Number3004593495-2020-00112
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeAS
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,Followup
Report Date 04/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
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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