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 foreign,health professional report with the FDA on 2019-11-22 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.

MAUDE Entry Details

Report Number3004593495-2019-01227
MDR Report Key9363618
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2019-10-31
Date Mfgr Received2019-10-31
Date Added to Maude2019-11-22
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 Received2019-11-22
Model Number24970A
Catalog Number24970A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPLEXUS MANUFACTURING SDN. BHD
Manufacturer AddressBAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2019-11-22

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