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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1788TC
Device Problem Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This ra lead was implanted on (b)(6) 2007 and was explanted on (b)(6) 2013 due to unknown product issue.The physician was dr.(b)(6) at (b)(6) in (b)(6), al.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
PERMANENT PACEMAKER ELECTRODE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17523584
MDR Text Key321346161
Report NumberMW5130532
Device Sequence Number1
Product Code DTB
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 06/17/2013
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 Number1788TC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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