SOLARA CRT-P MRI SURESCAN W1TR03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-14 for SOLARA CRT-P MRI SURESCAN W1TR03 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[187335733] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187335734] Additional information was received and reported the device was replaced at the same time as a changeout from an epicardial to a transvenous system and was unrelated to the battery voltage measurement.
Patient Sequence No: 1, Text Type: D, B5


[188226748] Concomitant medical products: 310c31 tissue valve, implanted: (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188226749] It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p). The device was explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[188944994] Secondary review of the reported event determined that there is improbable risk to the patient associated with this issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188944995] It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p) which did not affect device performance. The device was explanted and replaced at the same time as a changeout from an epicardial system to a transvenous system and was unrelated to the battery voltage measurement. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-05382
MDR Report Key9832575
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-14
Date of Report2020-04-02
Date of Event2019-09-21
Date Mfgr Received2020-03-26
Device Manufacturer Date2019-02-11
Date Added to Maude2020-03-14
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 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 NameSOLARA CRT-P MRI SURESCAN
Generic NamePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Product CodeNKE
Date Received2020-03-14
Model NumberW1TR03
Catalog NumberW1TR03
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
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
101. Hospitalization; 2. Required No Informationntervention 2020-03-14

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