CG FUTURE BAND 638BL36

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 2020-02-25 for CG FUTURE BAND 638BL36 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[180741426] 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. Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure and can be resolved with medical treatment or the implant of a permanent pacemaker. A conduction disturbance does not indicate a device malfunction or potential manufacturing issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[180741427] Medtronic received information that 3 days post implant of this 36mm mitral annuloplasty band, a permanent pacemaker was implanted in the patient. The reason for the permanent pacemaker implant was reported as sick sinus syndrome. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-00565
MDR Report Key9750333
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2014-04-28
Date Mfgr Received2020-02-12
Device Manufacturer Date2012-08-08
Date Added to Maude2020-02-25
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 NameCG FUTURE BAND
Generic NameRING, ANNULOPLASTY
Product CodeKRH
Date Received2020-02-25
Model Number638BL36
Catalog Number638BL36
Device Expiration Date2017-07-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-02-25

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