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Model Number 2188-75 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Cardiomyopathy (1764); Liver Damage/Dysfunction (1954); Tricuspid Regurgitation (2112); Ascites (2596)
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Event Date 12/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 8042b crtp, implanted: (b)(6) 2007; fr995-27 tissue valve, implanted: (b)(6) 2002; mcs-p3-29-aoa-us transcatheter valve, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient experienced tricuspid regurgitation and non-ischemic cardiomyopathy leading to liver dysfunction and ascites requiring multiple paracenteses.It was further reported that there was severe pulmonary right ventricle, right atrial and increased right atrial pressure.During the procedure to replace the tricuspid valve, the right ventricular (rv) lead and the left ventricular (lv) lead were found to be crossing the tricuspid annulus.The left ventricular (lv) lead was also noted to not be in the left ventricle, but was in the right ventricle through the tricuspid valve.Both the rv and the lv leads were explanted and replaced.The tricuspid valve was also replaced.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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