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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE
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MEDTRONIC PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4092
Device Problems Energy Output Problem (1431); Over-Sensing (1438); Pacing Intermittently (1443)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the patient left ventricular (lv) lead showed a yellow alert for intrinsic amplitude out-of-range measurements.Technical services (ts) reviewed the case and discussed dally measurements collection, ts could not determine what the device saw and grabbed for this measurement.Could have been a premature atrial and/or ventricular contractions.In addition, ts noticed that the patient previously had an episode of right ventricular (rv) lead oversenslng with 2 seconds of pacing inhibition.It was recommended to inquire the patient if any procedures were being performed at the time of this episode.If no electromagnetic interference (emi) is the reason of this, lead integrity evaluations should be performed.Due to the rv longevity, this could be the beginning of an insulation issue.Further information was received indicating that evaluations were performed, but no integrity issues could be confirmed on the leads.This rv lead remains in service and no adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PERMANENT PACEMAKER ELECTRODE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17531489
MDR Text Key321050759
Report NumberMW5138404
Device Sequence Number1
Product Code DTB
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 03/09/2022
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 Number4092
Patient Sequence Number1
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