MAUDE Adverse Event Report: MEDTRONIC RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4568

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)

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

Event Type  malfunction  

Event Description

It was reported that this right atrial (ra) lead exhibited a right atrial automatic threshold (raat) alert for unsuccessful testing due to noise.The device was reprogrammed at that time.Additional information was later received which reported that there was ra oversensing of right ventricle signals, as well as stored episodes ra noise and oversensing.Boston scientific technical services (ts) noted that this oversensing appeared to be related to the minute ventilation imv) feature.The feature was deactivated by the signal artifact monitor (sam).The ra impedance measurement was elevated during the sam episode, but was not out of range.No adverse patient effects were reported.The lead remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17530227
• MDR Text Key: 321407783
• Report Number: MW5137147
• 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: 12/17/2020

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: 4568
• Patient Sequence Number: 1