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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2017
Event Type  Malfunction  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported an error message appeared during implant indicating the programmed value or programmed mode could not be accepted and to exit the pop-up box and select a new parameter. This occurred after the user tried to assess lv (left ventricular) lead placement, while testing lv tip to ring configuration. As a result, a pacing mode or rate to analyze the lead could not be set. The user then exited the pop-up and tried to re-select, but the system locked, would not allow them to advance, and wouldn't launch after. The application was forced closed, and the base station power was disconnected and reconnected, which did not work. Finally, a soft reset of the tablet worked. A different programmer/analyzer model was used to finish the case. The mobile programmer application remains in use. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Analysis summary: the reported out of specification issues with the mobile programmer application were confirmed. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported an error message appeared during implant indicating the programmed value or programmed mode could not be accepted and to exit the pop-up box and select a new parameter. This occurred after the user tried to assess lv (left ventricular) lead placement, while testing lv tip to ring configuration. As a result, a pacing mode or rate to analyze the lead could not be set. The user then exited the pop-up and tried to re-select, but the system locked, would not allow them to advance, and wouldn't launch after. The application was forced closed, and the base station power was disconnected and reconnected, which did not work. Finally, a soft reset of the tablet worked. A different programmer/analyzer model was used to finish the case. The mobile programmer application remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameCARELINK SMARTSYNC
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6780194
MDR Text Key82486810
Report Number3004593495-2017-00397
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/22/2017
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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