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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; HART

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ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; HART Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complete Heart Block (2627)
Event Date 07/29/2019
Event Type  Injury  
Manufacturer Narrative
Investigation results will be provided in the final report.Further information regarding the event were requested but not received.
 
Event Description
During a procedure, heart block occurred.The catheter brushed against the membrane of the fossa ovalis, causing heart block.Pacing off the coronary sinus catheter was performed to resolve the heart block.The procedure was completed and the patient was stabilized.
 
Manufacturer Narrative
An event of heart block was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information regarding the event were requested but not received.
 
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Brand Name
ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
Type of Device
HART
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8861957
MDR Text Key153400351
Report Number3005334138-2019-00424
Device Sequence Number1
Product Code MTD
Combination Product (y/n)N
PMA/PMN Number
K172393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/05/2019
Supplement Dates Manufacturer Received08/13/2019
Supplement Dates FDA Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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