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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 4524
Device Problem Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 08/23/2016
Event Type  malfunction  
Event Description
This ra lead was implanted on (b)(6) 1995 and was capped on (b)(6) 2016 due to an unknown product performance issue.The physician was dr.(b)(6) of (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 Key17523257
MDR Text Key321335909
Report NumberMW5130205
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 01/13/2017
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 Number4524
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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