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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; ELECTRODE, PACEMAKER, TEMPORARY
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; ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Lot Number QABACP
Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/20/2021
Event Type  malfunction  
Event Description
Physician notified staff that tip of the pacing wire may remain in patient because it was missing upon removal of the pacing wire in pcicu (pediatric cardiac intensive care unit).Arnp (advanced registered nurse practitioner) attempted to remove pacing wire, but felt resistance so physician was consulted for the removal.Tip of pacing wire.X-ray was done.Md called to bedside to remove patient's external pacing wires due to resistance being met when pulled.When md removed wires, it was noted that tip of wire was missing.X-ray was ordered and pacing wire was noted to be retained in heart.Md, cvicu (cardiovascular intensive care unit) team and parents aware.Md has been rounding and reassuring the family daily on regards to the tips of the pacing wire remaining in the patient.
 
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Type of Device
ELECTRODE, PACEMAKER, TEMPORARY
MDR Report Key12128107
MDR Text Key262723781
Report Number12128107
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberQABACP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2021
Event Location Hospital
Date Report to Manufacturer07/07/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age2190 DA
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