MAUDE Adverse Event Report: ST. JUDE MEDICAL PERMANENT PACEMAKER ELECTRODE

Model Number 1882TC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2011

Event Type  malfunction  

Event Description

This lead was attempted to be implanted on (b)(6) 2011.The lead would not stay fixed and there was tissue stuck to the helix so it was removed.The procedure took place at (b)(6)with dr.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17517344
• MDR Text Key: 321242660
• Report Number: MW5124293
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1882TC
• Patient Sequence Number: 1