MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5593

Device Problems Failure to Capture (1081); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Technical services received a call on (b)(6) 2012 from sales rep.Lead implanted on (b)(6) 2012.Atrial lead.Today upon checking, int capture, p-waves non-existent or intermittent.Re-positioned the lead today.Lead had moved some - slack had gotten taken out.New location and all numbers are fine.No impact to patient.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): MEDTRONIC
• MDR Report Key: 17517673
• MDR Text Key: 321069163
• Report Number: MW5124621
• 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: 08/10/2012

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: 5593
• Patient Sequence Number: 1