PATIENT CABLE 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 2019-05-20 for PATIENT CABLE 5487 manufactured by Medtronic, Inc..

Event Text Entries

[145538194] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[145538195] It was reported that the cables would not capture when connected to the leads and to an external pulse generator (epg). The physician then opted to connect the leads to an implantable pulse generator (ipg) that was taped externally to the patient's neck until a device could be implanted. The cables are expected to be returned for service. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182208-2019-00934
MDR Report Key8624881
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-20
Date of Report2019-06-04
Date of Event2019-05-10
Date Mfgr Received2019-05-23
Device Manufacturer Date2018-06-25
Date Added to Maude2019-05-20
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 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 NamePATIENT CABLE
Generic NameCABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Product CodeDSA
Date Received2019-05-20
Returned To Mfg2019-05-21
Model Number5487
Catalog Number5487
Lot Number675820001
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
150761. Required No Informationntervention 2019-05-20

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