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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 LPA1200M
Device Problem Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This rv lead was implanted on (b)(6) 2018 and was explanted on (b)(6) 2018 due to an unknown product performance issue.The physician was dr.(b)(6) at (b)(6) in (b)(6).No other information is available.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 Key17516789
MDR Text Key321232266
Report NumberMW5123738
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 10/17/2018
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 NumberLPA1200M
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/11/2023
Patient Sequence Number1
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