Model Number U125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endocarditis (1834); Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191); Pericardial Effusion (3271)
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Event Date 11/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis.An echocardiogram was performed, and vegetation was seen on the leads.Subsequently, a revision procedure was performed.It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure.The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed.The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis.An echocardiogram was performed, and vegetation was seen on the leads.Subsequently, a revision procedure was performed.It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure.The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed.The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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