MAUDE Adverse Event Report: MEDTRONIC PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDRL1

Device Problems Nonstandard Device (1420); Over-Sensing (1438); Pacing Inadequately (1442)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this device was explanted due to advisory or recall on (b)(6) 2019.It was noted that there was oversensing resulting in an unexpected pacing rate prior to the explant.No additional adverse patient effects were reported.The patient's leads remain in service with the patient's new pacemaker.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17535508
• MDR Text Key: 321173380
• Report Number: MW5142404
• Device Sequence Number: 1
• Product Code: NVZ
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ADDRL1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1