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

MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

  • 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
 

ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 1888TC
Device Problems Electromagnetic Interference (1194); Decreased Sensitivity (2534)
Patient Problem Tachycardia (2095)
Event Type  Injury  
Event Description
This rv lead was implanted on (b)(6) 2009 and remains implanted as of the present.A call placed to technical services on 04/12/2018 stating that ventricular episode was observed at 4:00am on april 2 that looks like myopotential and is reproducible when patient rolls from side to side but was not oversensed.Few drop in impedance from around 450-500 down to 350 ohm was also observed.The patient had an underlying rhythm of approximately 30 and a 2 second pause.The health care professional (hcp) stated it looked like electromagnetic interference with some fuzz and decrease the sensitivity.The following physician was dr.(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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17535897
MDR Text Key321136129
Report NumberMW5142790
Device Sequence Number1
Product Code NVZ
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 07/10/2018
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 Number1888TC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
-
-