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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 Pacing Problem (1439); Communication or Transmission Problem (2896)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 09/10/2019
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 mobile programmer application lost connection with the implantable device during left ventricular (lv) lead placement. The user tried re positioning the patient connector over the device, but was unable to regain the connection. As the leads were being sutured in, the user ended the device session hoping to regain connection. As the device session ended, pacing stopped via the analyzer. The analyzer had been pacing throughout the procedure as a backup. The patient had an escape rhythm until the analyzer was able to be re-launched. The mobile programmer application remains in use. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product analysis: it was determined at analysis that the one hour inactivity timeout on the mobile programmer application failed. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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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 Key9038693
MDR Text Key158801764
Report Number3004593495-2019-00947
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2018
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: 09/13/2019 Patient Sequence Number: 1
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