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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

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ST. JUDE MEDICAL DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE Back to Search Results
Model Number 2088TC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that this ra was explanted due to a product performance issue.It was successfully replaced with a lead from a different manufacturer.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Type of Device
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17529461
MDR Text Key321433067
Report NumberMW5136387
Device Sequence Number1
Product Code NVN
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 11/05/2021
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
Device Model Number2088TC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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