MELODY TRANSCATHER PULMONARY VALVE PB1018

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 2019-12-12 for MELODY TRANSCATHER PULMONARY VALVE PB1018 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[185013197] Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185013198] Medtronic received information that approximately five years and three months following the implant of this pulmonary transcatheter bioprosthetic valve, a new valve was implanted in the same position for an unknown reason. No additional adverse patient effects were reported.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2019-03755
MDR Report Key9458103
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-12
Date of Report2020-03-11
Date of Event2019-11-15
Date Mfgr Received2020-02-18
Device Manufacturer Date2014-06-12
Date Added to Maude2019-12-12
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 STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVES DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMELODY TRANSCATHER PULMONARY VALVE
Generic NamePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Product CodeNPV
Date Received2019-12-12
Model NumberPB1018
Catalog NumberPB1018
Device Expiration Date2016-05-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVES DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-12-12

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