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

Model Number 4196

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2010 and still remains implanted at this time.The physician was dr.(b)(6) a call to technical services states that patient was shocked twice.It was also noted in histograms that rv pacing is at 78% but l v pacing at 27%.Discussed reason this could happen could be that lv is picking up left sided ventricular activity, picking up atrial activity, or lv lead noise.Thresholds have risen so suggested a cxr to verifiy lead placement.Discussed turning off lv sensing or changing lv configuration to get better sensing and pacing thresholds.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: 17528263
• MDR Text Key: 321409116
• Report Number: MW5135194
• 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: 05/24/2013

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: 4196
• Patient Sequence Number: 1