CRT | 合法醫療器材資訊網

UrgentmedicaldevicerecallforCardiacResynchronizationTherapyDefibrillators(CRT-Ds)andImplantableCardioverterDefibrillators(ICDs).

For a Subset of Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs)

Model Listing in Appendix A

March 2018,

Dear Physician or Healthcare Professional,

This letter is to inform you of a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs) (see Appendix A) that may have undergone a specific sequence of manufacturing processes that could lead to an out-of-specification internal gas environment. This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy. This specific manufacturing sequence is no longer performed. There have been...

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