TEMPO TEMPORARY PACING LEAD T1106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-13 for TEMPO TEMPORARY PACING LEAD T1106 manufactured by Biotrace Medical, Inc..

MAUDE Entry Details

Report Number3013472601-2019-00001
MDR Report Key9038803
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-13
Date of Report2019-09-12
Date of Event2019-08-11
Date Mfgr Received2019-08-13
Date Added to Maude2019-09-13
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 ContactMR. KEN XAVIER
Manufacturer Street3925 BOHANNON DR. SUITE #200
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal94025
Manufacturer Phone6507794999
Manufacturer G1BIOTRACE MEDICAL, INC.
Manufacturer Street3925 BOHANNON DR. SUITE #200
Manufacturer CityMENLO PARK,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTEMPO TEMPORARY PACING LEAD
Generic NameTEMPORARY PACING LEAD
Product CodeLDF
Date Received2019-09-13
Model NumberT1106
Catalog NumberT1106
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOTRACE MEDICAL, INC.
Manufacturer Address3925 BOHANNON DR. SUITE #200 MENLO PARK CA 94025 US 94025


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-13

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