• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 5071
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This rv lead was implanted on (b)(6) 2005 and remains implanted at this time.A call was placed to technical services on 07/13/2016 in which it was reported that patient presented to emergency room with high inr.100% paced.Md wanting to know longevity.Transmission sent showed high rv output 5v 1@ 1msec.1 low r wave noted however patient is 96% ap, 100 vp, impedance stable.Date was on (b)(6) that cannot be reviewed.The physician was dr.(b)(6) in (b)(6) specialists at (b)(6).No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERMANENT PACEMAKER ELECTRODE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17537050
MDR Text Key321269151
Report NumberMW5143932
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
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number5071
Patient Sequence Number1
-
-