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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 1156T
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there were episodes of noise on this lv lead that were oversensed, resulting in brief periods of pacing inhibition.The patient's device was reprogrammed to turn off sensing on this lead.No adverse patient effects were reported.The lead remains in service.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 Key17533687
MDR Text Key321463326
Report NumberMW5140591
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 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number1156T
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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