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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 5071
Device Problem Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 03/21/2013
Event Type  malfunction  
Event Description
This lead was implanted on (b)(6) 2012 and was capped on (b)(6) 2013 due to an unknown product performance issue.The physician was dr.(b)(6) at (b)(6) medical center in (b)(6).No addititonal 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 Key17523294
MDR Text Key321380044
Report NumberMW5130242
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 Number5071
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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