Safety Alert Or Field Safety Notices for Isoline implantable cardioverter defibrillator (ICD) leads

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 inappropriate shocking, pacing inhibition or shocking inhibition due to internal insulation abrasion.Sorin has identified abrasion of internal silicone insulation in 30 returned Isoline leads. This equates to 0.2% of worldwide sales since product launch in 2005. However, the proportion is expected to rise, partly as a result of closer patient follow-up subsequent to this field action. Only one of these incidents occurred in the UK out of approximately 380 leads distributed and none of the incidents was fatal. These incidents typically presented as inappropriate shocks and low pacing impedance, as well as ventricular oversensing where pacing was inhibited. Affected leads were implanted for between 2 months and 4.5 years prior to failure.Analysis of returned leads revealed insulation abrasion, where the microcables contained within the defibrillator coil were not directly covered with ETFE polymer coating. This abrasion occurred predominantly under the right ventricular electrode, but also under the superior vena cava electrode, when torsion or compression of the lead had occurred.  For electrical malfunction to occur, the microcable must abrade towards, and make contact with, the pacing-sensing conductor. Microcable abrasions occur within the defibrillator coil and cannot be detected by X-ray imaging.Sorin has suspended distribution of all models of the Isoline lead and is recalling all un-implanted stock. The company communicated this to all its customers in an ‘Urgent Medical Device Field Safety Notice (67Kb)’ issued on 28 January 2013.