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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

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MEDTRONIC PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4058M
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This lead was implanted on (b)(6) 1993 and was explanted on (b)(6) 2013.A call to technical services placed on (b)(6) 2013 states that this lead is scheduled for lead revision on the day of call.The physician was dr.(b)(6) at (b)(6) hospital 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
PERMANENT PACEMAKER ELECTRODE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17534819
MDR Text Key321512843
Report NumberMW5141718
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 Number4058M
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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