Model Number U228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
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Event Date 01/18/2021 |
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 indicated that their incision never healed and they were recently hit in that area.A sore and opening were noted on the incision line.Subsequently, a revision procedure was performed.This crt-p, right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead were explanted due to infection and sepsis.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient indicated that their incision never healed and they were recently hit in that area.A sore and opening were noted on the incision line.Subsequently, a revision procedure was performed.This crt-p, right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead were explanted due to infection and sepsis.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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Search Alerts/Recalls
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