VIVA? QUAD S CRT-D DTBB1Q1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for VIVA? QUAD S CRT-D DTBB1Q1 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185738675] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185738676] It was reported that the cardiac resynchronization therapy defibrillator (crt-d) battery life was declining earlier than expected. The device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[186458186] Product event summary: the device was not returned for analysis. However, performance data collected from the device was received and analyzed. Analysis of the device memory showed the battery is approaching the indicator signifying the time for device replacement. 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 Number3004209178-2020-06408
MDR Report Key9901014
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-30
Date of Report2020-04-03
Date of Event2020-03-05
Date Mfgr Received2020-03-31
Device Manufacturer Date2015-10-14
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 PUERTO RICO OPERATIONS CO.
Manufacturer StreetROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
Manufacturer CityJUNCOS PR 00777
Manufacturer CountryUS
Manufacturer Postal Code00777
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIVA? QUAD S CRT-D
Generic NameDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Product CodeNIK
Date Received2020-03-30
Model NumberDTBB1Q1
Catalog NumberDTBB1Q1
Device Expiration Date2017-04-14
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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