Safety Alert Or Field Safety Notices for Implantable pacemakers

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Risk of loss of pacing due to overestimation of the time remaining to elective replacement indicator (ERI).Sorin has received 8 reports where the residual longevity determined during follow-up was overestimated due to a software inaccuracy. This has arisen as a result of a difference between predicted and actual pacemaker battery depletion characteristics. All reports reached ERI within 4 to 5 years and involved pacemakers programmed with high pulse amplitude and width, combined with a high percentage of paced events.Over 20,000 pacemakers affected by this issue have been distributed in the UK since 2007.The manufacturer has determined that the majority of affected pacemakers should not reach ERI within 8 years of implantation. However, it is important to note that this time may be significantly reduced for pacemakers with high programmed settings, for example in the case of pacing-dependent patients. It is also important to be aware that there are differences in nominal longevity between the pacemaker models (under Cenelec conditions of 70 min-1, 2.5V, 0.5ms). Reply DR and Reply D models have an expected nominal longevity of less than 8 years; being 7.1 and 7.4 years respectively, compared with Reply VDR and Reply SR at 9 years and 9.3 years respectively. Within the UK approximately 250 Reply DR and Reply D models were sold over 6 years ago. Early implants of these pacemaker models may be among the first to reach ERI, especially where they have a high percentage of pacing and/or high output settings.The manufacturer will be issuing a new programmer software version to correct the quoted time to ERI and its presentation through the colour-coded gauge. All upgrades are expected to be completed in the UK within three months. However, the need for 6 monthly follow-up when the battery impedance reaches 3.5kΩ will remain.Sorin distributed a Field Safety Notice (40Kb) concerning this issue to affected customers on 20 November 2013.