MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2013 and remains implanted at this time.A call to technical services placed on (b)(6) 2013 states that there was too much slack with the atrial lead which caused it to prolapse in the valve which produced superior vena cava syndrome.The lead electrically was performing well.The patient was symptomatic, so they removed about 1-2 cm of slack by pulling the lead back a bit.This was done at (b)(6) hospital by dr.(b)(6).They closed the pocket up and sent the patient home.No other information is provided.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: 17524843
• MDR Text Key: 321134888
• Report Number: MW5131786
• 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: 12/17/2013

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: 5076
• Patient Sequence Number: 1