ATTAIN SELECT II 6248V-130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for ATTAIN SELECT II 6248V-130 manufactured by Medtronic, Inc..

Event Text Entries

[185933190] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185933191] It was reported that the patient experienced hypotension, pericardial effusion, and cardiac tamponade. During implant of the left ventricular (lv) lead, the lead was successfully positioned into an acceptable venous branch (only viable one available) but dislodged twice from the branch. During a final attempt at sub-selecting the target vein with a sub-selector catheter, cardiac tamponade was diagnosed. It was also reported that a coronary sinus dissection and perforation had occurred. Medication was administered, and a pericardiocentesis was performed. The lv lead was not implanted, and lv port was capped. The patient was hospitalized for approximately one week, and was recovering well. The ra lead, rv lead and cardiac resynchronization therapy device remain in use. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182208-2020-00583
MDR Report Key9881009
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-30
Date of Event2020-03-02
Date Mfgr Received2020-03-30
Date Added to Maude2020-03-25
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 ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATTAIN SELECT II
Generic NameCATHETER, PERCUTANEOUS
Product CodeDQY
Date Received2020-03-25
Model Number6248V-130
Catalog Number6248V-130
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-03-25

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