CARELINK SMARTSYNC BASE 24970A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.

Event Text Entries

[181159838] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[181159839] It was reported that during an implant procedure, the mobile programmer application froze suddenly and came to a halt. The application was deleted and re-booted, but all of the data from the procedure had disappeared. The mobile programmer application remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[188584353] Product event summary: analysis determined that the issue occurred due to the application background foreground event. The user opened the report to view and pushed the application to the background while viewing the portable document format (pdf) and then resumed the application after a long time and the application was not able to recover the sockets, hence the application was frozen. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004593495-2020-00187
MDR Report Key9750097
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-25
Date of Report2020-03-02
Date of Event2020-01-30
Date Mfgr Received2020-02-26
Date Added to Maude2020-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1PLEXUS MANUFACTURING SDN. BHD
Manufacturer StreetBAYAN LEPAS FREE INDUSTRIAL ZO
Manufacturer CityBAYAN LEPAS 11900
Manufacturer CountryMY
Manufacturer Postal Code11900
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARELINK SMARTSYNC BASE
Generic NameANALYZER, PACEMAKER GENERATOR FUNCTION
Product CodeDTC
Date Received2020-02-25
Model Number24970A
Catalog Number24970A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPLEXUS MANUFACTURING SDN. BHD
Manufacturer AddressBAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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