5487

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 2016-12-09 for 5487 manufactured by Medtronic, Inc..

Event Text Entries

[62081217] 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.
Patient Sequence No: 1, Text Type: N, H10


[62081218] It was reported before coronary artery bypass surgery, a cable had been placed and plugged in to an external pacemaker. During the procedure, the product showed a dysfunction which caused the patient cardiac arrest. It had been replaced by another of the same lot which presented the same default. The plug between electrodes and wire connection seemed to be deficient. When the connection was moved, sometimes it worked again. During this, the patient received an internal heart massage. Finally the cable was replaced by a different model cable. The cables were returned for analysis. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[67350695] Product event summary: manufacturer's analysis was unable to confirm the customer comments regarding the cable. During analysis, the cable passed all visual incoming inspection with no anomalies found, and the cable passed all continuity tests with no intermittent or shorted connections found.
Patient Sequence No: 1, Text Type: N, H10


[96126666] 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 Number2182208-2016-02749
MDR Report Key6162043
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-12-09
Date of Report2016-12-15
Date of Event2016-10-20
Date Mfgr Received2016-12-15
Device Manufacturer Date2016-03-31
Date Added to Maude2016-12-09
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 ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameCABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Product CodeDSA
Date Received2016-12-09
Returned To Mfg2016-11-25
Model Number5487
Catalog Number5487
Lot Number553060001
Device Expiration Date2018-03-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2016-12-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.