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The unbearable insensitivity of risk management language

Ronen E

Problem Solver
Staff member
Super Moderator
Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor. The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices. Of the devices recalled in the US, 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaint or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.
(Emphasis added)

Sure, no patient harm has occurred, except for the need to undergo explantation and re-implantation... easy.
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