MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 4194

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead exhibited intermittent impedances as high as 2000 ohms and noise that was oversensed which resulted inappropriate shocks.The patient did not experience any pacing inhibition.Subsequently, this rv lead was surgically abandoned and it was determined that the lead was fractured.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 LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17524541
• MDR Text Key: 321415612
• Report Number: MW5131487
• Device Sequence Number: 1
• Product Code: OJX
• 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: 03/08/2021

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: 4194
• Patient Sequence Number: 1