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

Model Number 4298

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Event Description

It was reported that the patient was having diaphragm stimulation with this cardiac resynchronization therapy pacemaker (crt-p).The patient stated that the stimulation occurred when lying down on the side.Boston scientific technical services (ts) changed the left ventricular (lv) lead paced vector to 2-can, and output as per rep was left at 3.5 vat 0.4 ms.The device remains in service.No 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: 17364917
• MDR Text Key: 319515069
• Report Number: MW5119719
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4298
• Device Lot Number: QUA237905V
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention