LEGEND II 8427

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-23 for LEGEND II 8427 manufactured by Mdt Puerto Rico Operations Co, Med Rel.

MAUDE Entry Details

Report Number2647346-2019-00019
MDR Report Key9225893
Report SourceCONSUMER
Date Received2019-10-23
Date of Report2019-10-23
Date of Event1993-06-20
Date Mfgr Received2019-09-27
Date Added to Maude2019-10-23
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 G1MDT PUERTO RICO OPERATIONS CO, MED REL
Manufacturer StreetROAD 909, KM. 0.4., BARRIO MAR
Manufacturer CityHUMACAO PR 00792
Manufacturer CountryUS
Manufacturer Postal Code00792
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEGEND II
Generic NamePULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE
Product CodeLWO
Date Received2019-10-23
Model Number8427
Catalog Number8427
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMDT PUERTO RICO OPERATIONS CO, MED REL
Manufacturer AddressROAD 909, KM. 0.4., BARRIO MAR HUMACAO PR 00792 US 00792


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-10-23

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