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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CRYO CONSOLE AND CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER
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MEDTRONIC, INC. CRYO CONSOLE AND CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Device Problems Temperature Problem (3022); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
Our brand new cryo consoles are not working properly.Management, and medtronic support are looking for answers as to why.Prior consoles which were removed out of service, never had these issues.Temp variations during ablation shut down the system.This has been an issue since we started using these systems.If these issues are not resolved, patients who require this particular type of ablation will have to go elsewhere for care.This malfunction added at least one hour plus to the patient's procedure time, and increased cost to the patient by adding additional products to the field for trouble shooting.
 
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Brand Name
CRYO CONSOLE AND CATHETER
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key15914815
MDR Text Key304814390
Report Number15914815
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/14/2022
Event Location Hospital
Date Report to Manufacturer12/05/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age6205 DA
Patient SexMale
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