MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5076

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Intermittently (1443)

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

Event Type  malfunction  

Event Description

It was reported that the patient has a history of noisy signals on the right atrial (ra) lead, and recently the noisy signals were noticed on this right ventricular (rv) lead as well, causing oversensing and pacing inhibition of more than 2 seconds.Technical services (ts) reviewed the case and confirmed noise in both leads, although indicating that rv lead measurements are within range.The clinic indicated that no aggressive troubleshooting will be performed due to the patient's age and making the device less sensitive was considered in the rv lead.It was inquired if signal amplitude can be measured and ts indicated this cannot be done remotely, but the event should be in the device and on the programmer the amplitude can be measured.Ts recommended to perform isometrics and serial impedance for further evaluation.Subsequently, the patient came to the clinic for device interrogation and troubleshooting, isometrics and x-rays were performed, no integrity issues were found with the leads.Rv sensitivity was reprogrammed, and the patient will continue to be monitored.This rv lead remains in service and no additional 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: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17525197
• MDR Text Key: 321431108
• Report Number: MW5132139
• Device Sequence Number: 1
• Product Code: NVN
• 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: 03/09/2022

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