MAUDE Adverse Event Report: VIATRON MEDICAL (MEDTRONIC) PERMANENT PACEMAKER ELECTRODE

Model Number IMD49B

Device Problems High Sensing Threshold (2574); Impedance Problem (2950)

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

Event Type  malfunction  

Event Description

It was reported that an alert was "triggered" via remote monitoring system due to out of range pace impedance measurements when it comes to this device.An increase in pacing thresholds was also noted.Lead damage was suspected.The system remains implanted.No adverse patient effects were reported.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): VIATRON MEDICAL (MEDTRONIC)
• MDR Report Key: 17527100
• MDR Text Key: 321074865
• Report Number: MW5134036
• 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: 08/28/2019

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: IMD49B
• Patient Sequence Number: 1