5487

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 2016-10-06 for 5487 manufactured by Medtronic, Inc..

Event Text Entries

[56767464] Product event summary: manufacturer's analysis was unable to confirm the customer comment that the cable would not allow pacing and capture. The cable passed all visual incoming inspection with no anomalies found. The cable also passed continuity testing with no intermittent or shorted connections found. 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


[56767465] It was reported that the temporary pacing cable was connected to a patient's lead and pacing and capture did not occur. The patient experienced long periods of asystole as a result. The cable was replaced and returned for analysis. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[96050064] 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 Number2182208-2016-02548
MDR Report Key6009856
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-10-06
Date of Report2016-08-03
Date of Event2016-08-03
Date Mfgr Received2016-08-03
Date Added to Maude2016-10-06
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 Received2016-10-06
Returned To Mfg2016-08-09
Model Number5487
Catalog Number5487
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2016-10-06

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