NBIH? TEMPORARY PACING ELECTRODE CATHETER 007153P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-31 for NBIH? TEMPORARY PACING ELECTRODE CATHETER 007153P manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[183167696] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[183167697] It was reported that the bipolar pacing electrode catheter would not power up, and the hose was changed but the device still did not work. Another probe was used on the patient to complete the procedure but the procedure was delayed and the patient was in a delicate state. Per additional information from the ibc via email 09jan2020, the device would not produce an electrical current or pace. The patient did not require additional sedatives or medication to maintain cardiac output while the electrodes were switched out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-00684
MDR Report Key9653526
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-01-31
Date of Report2020-03-03
Date of Event2019-12-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-11-19
Date Added to Maude2020-01-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNBIH? TEMPORARY PACING ELECTRODE CATHETER
Generic NameBIPOLAR PACING ELECTRODE CATHETER
Product CodeLDF
Date Received2020-01-31
Returned To Mfg2020-01-22
Model Number007153P
Catalog Number007153P
Lot NumberGFDW1815
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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