FDA Adverse Event Malfunction Summary report: N

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

MDR report key: 17524075 · Received August 12, 2023

Report

Report Number
MW5131022
Event Type
Malfunction
Date Received
August 12, 2023
Report Date
February 2, 2012
Manufacturer
MEDTRONIC
Product Code
OJX
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

THIS LV LEAD WAS IMPLANTED ON (B)(6) 2011. A CALL TO TECHNICAL SERVICES ON 1/5/12 STATES THAT REP HAD A QUESTION ABOUT LVPP - WHAT IS ALGORITHM? TS STATED THAT WITH LVPP IF SOMETHING SENSED ON LEFT SIDE THEN WILL INHIBIT ANY LV PACE SCHEDULED DURING LVPP. CALLER STATED THAT PATIENT IS ONLY 7% LVP. CALLER SEEING LVP-LNH IN REAL-TIME. TS ASKED IF CAN SEE IF LVS LINING UP WITH ATRIAL ACTIVITY IF SURFACE ON? CALLER DID NOT HAVE SURFACE ON PATIENT. CALLER STATED THAT PATIENT IS 97% RVP. LVS COMING IN ABOUT 8MS BEFORE RVP. TS STATED COULD TRY TURNING ON LV OFFSET TO SEE IF COULD GET LVP BEFORE LVS. CALLER COULD NOT GET LVP WITH LV OFFSET OF -50MS. TS STATED THAT LV LEAD IS BIPOLAR SO COULD TRY DIFFERENT LV CONFIGURATION. CALLER STATED THAT LV CONFIG WAS SPLIT AT IMPLANT. CALLER TRIED CHANGING SENSING LV CONFIG AND WAS ABLE TO GET LVP. CALLER TRIED TURNING BACK OFF LV OFFSET BUT THEN LVP WAS INHIBITED AGAIN. CALLER TRYING DIFFERENT LV CONFIGURATIONS TO FIND ONE THAT WORKS BEST WITH SMALLEST LV OFFSET. CALLER WANTED TO KNOW WHAT COULD BE CAUSING THIS? TS STATED IT IS UNUSUAL FOR CRT PATIENTS TO HAVE LEFT SIDE ACTIVATE BEFORE RIGHT SIDE, LIKE RBBB. COULD STILL BE PICKING UP ATRIAL ACTIVITY - WOULD WANT TO CHECK THAT. CALLER WILL TRY DIFFERENT OFFSET/SENSING CONFIG TO SEE IF CAN GET LVP. MD IS DR. (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2218265 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC 4196

Patients

Seq Age Sex Outcome Treatment
1 Unknown