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); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that dunng a dox change upgrade procedure, noise was notea with the old competitor right ventricular (rv) lead when plugged into the new cardiac resynchronization therapy pacemaker (crt-p) system.The physician decided to clean the rv port of the new device header, use a dry sterile paper and implanted a new rv lead.The patient came in for a post-procedure follow-up visit, and noise was noted again in the rv channel.This device was reprogrammed.Data analysis was performed and boston scientific technical services confirmed the low amplitude noise in the rv sensing channel.Since the similar artifacts could be seen with the previous implanted competitor rv lead and now with the new rv lead, it was suspected that the noise was related to a physiological source.Due to the low amplitude of the signals, there appears to be no oversensing.Boston scientific technical services recommended additional troubleshooting at the next office visit.This patient is dependent and no adverse.Patient effects were reported.This crt-p system remains in service.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: 17536841
• MDR Text Key: 321133511
• Report Number: MW5143724
• 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: 01/18/2022

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