• 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 Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This lead was implanted on (b)(6) 2013 and remains implanted at this time.It was noted on 2013 that rv voltage output was programmed to automatic and was above capture threshold of 0.5 volts.The physician was dr.(b)(6) at (b)(6) clinic and hospital in (b)(6).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 Key17536158
MDR Text Key321515613
Report NumberMW5143048
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 08/13/2013
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 Number1888TC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
-
-