Field Safety Notice for Implantable Cardioverter Defibrillators EnTrust and EnTrust Escudo, Medtronic
2012.03.09
Product group Active implantable medical devices - defibrillators
Reference 01409/12
Medtronic has issued an urgent field safety notice on Implantable Cardioverter Defibrillators (ICD, Models EnTrust and EnTrust Escudo). Such ICD devices may not meet longevity or may not provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than expected drop in battery voltage.