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

Model Number 1388TC

Device Problems Failure to Capture (1081); Pacing Intermittently (1443)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2013

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2005 and was capped on (b)(6) 2013 due to pacing not delivered when required.Patient presented in emergency room with heart rate in 30's.Loss of capture noted on interrogation.Impedance fluctuations of >300 ohms noted in daily measurements.The physician was 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: 17526910
• MDR Text Key: 321411610
• Report Number: MW5133847
• 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: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1388TC
• Patient Sequence Number: 1