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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; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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ST. JUDE MEDICAL ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Cardiogenic Shock (2262)
Event Date 12/04/2020
Event Type  Injury  
Event Description
Related manufacturer ref: 2182269-2021-00020, 3005334138-2021-00087.The patient was admitted to the cardiovascular intensive care unit for vasopressor support of blood pressure for cardiogenic shock.Administration of the medications stabilized the patient.
 
Manufacturer Narrative
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 cardiogenic shock could not be conclusively determined.
 
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Brand Name
ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key11388670
MDR Text Key233973932
Report Number3005334138-2021-00131
Device Sequence Number1
Product Code DRF
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 03/05/2021
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 Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/26/2021
Supplement Dates Manufacturer Received03/02/2021
Supplement Dates FDA Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLEXABILITY ABLATION CATHETER, SE; LIVEWIRE DIAGNOSTIC CATHETER
Patient Outcome(s) Required Intervention;
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