It was reported that during a lead extraction procedure to remove one infected cardiac lead (rv), an injury occurred leading to death.Reportedly, the lead was prepped with an lld device, and a glidelight device was used to remove the lead.No signs of effusion or cardiac tamponade were present initially.Post extraction, a declining pressure was noticed, and after several minutes of attempted medical stabilization, the surgeon was called in.The extracting physician deployed a bridge rescue balloon and did a pericardiocentesis after confirmation of cardiac tamponade.The pressure increased and surgeon decided to perform a sternotomy.The balloon was deflated and a 1 cm tear was found at the apex of the rv.Bleeding remained persistent upon initial repair while identifying a second tear of < 0.5 cm on the svc.The patient went into vt and expired.
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B2): outcomes now reflected as "required intervention" instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on (b)(6) 2021.H1): type of reportable event corrected to "serious injury".H3): the device was discarded, thus no investigation could be completed.H6): heic code 1802 not applicable for this report; hecc code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that two mdr''s (1721279-2018-00009 and 1721279-2018-00010) were submitted for "death" for the same patient.This duplicated the patient''s death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2018-00009 will remain unchanged.
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