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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE UNKNOWN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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ST. JUDE UNKNOWN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pericardial Effusion (3271)
Event Date 07/22/2014
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2014, that during a right atrial tachycardia procedure the patient developed a pericardiai effusion that the physician felt was caused by the st.Jude quadrapolar catheter in the rv.A pericardialcentesis was performed.1200cc's were removed from the pericardial space.The patient was stabilized and transferred to the ccu for observation.Pl1-mu2g20 this report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
UNKNOWN
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
ST. JUDE
MDR Report Key17532484
MDR Text Key321139470
Report NumberMW5139392
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 08/12/2014
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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