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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T
Device Problem Malposition of Device (2616)
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Event Description
This lv lead was implanted on (b)(6) 2011.A call to technical services on (b)(6) 2011 states that patient is in chronic afib, with lead in a pretty high septal position.Patient having stim with the lv lead.Rep ran threshold test and had good capture at 2.1 and was able to program lv lead to 2.5/0.5 w/o stim in temp lv only under lead test in tip>rv and tip>can.With ring included, best threshold was 0.9 and there was stim at 1.2.Rep commented that when rv programmed to 5/0.5 and pacing was rv only there was no stim.But when rv and lv pace together, there is stim.Rep had to program vrr and biv trigger off due to stim.Dr.(b)(6) @ (b)(6) medical center was implanter and he did not want to go back in right now.Discussed that stim may be due to rv and/or lv lead position and one lead may need to be repositioned -maybe a lead moved as after implant and pocket being closed and/or leads coiled behind device.Discussed how with vrr in vvi non-tracking mode w/rv only (how patient is programmed), vrr is rv only, and since patient has stim in this manner, stim may have something to do with rv lead.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17523385
MDR Text Key321087003
Report NumberMW5130333
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number1258T
Patient Sequence Number1
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