Alerta De Seguridad O Notificaciones De Seguridad para Riata and Riata ST – all silicone coated models

Safety alert / Field Safety Notice

MDA/2012/061

CON184434

2012-09-10

2012-09-10

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON184434?tabName=allTabs

Risk of inappropriate shock or therapy failure due to wear of lead insulation after implantation. these patient follow-up recommendations replace those given previously in mda/2010/095 and mda/2011/112. in december 2011, the mhra issued a medical device alert (mda/2011/112) recommending enhanced patient follow-up for all patients implanted with riata and riata st lead models. at that time the frequency of follow-up was stratified according to lead model. current evidence suggests that the difference in prevalence of externalised cables between 8fr and 7fr lead models is decreasing. st jude medical has recently issued a field safety notice (dated 13 july 2012) detailing phase i of a riata lead evaluation study to investigate the prevalence of externalised cables using fluoroscopy. the clinical significance of externalised cables will not, however, be evident until phase ii of the study is completed; this is unlikely to be before the end of 2013. for this reason this medical device alert is focusing on detection of early signs of functional lead failure, as these lead models continue to fail at a higher rate.

Continue to follow up all patients implanted with Riata or Riata ST ICD lead models to identify any changes in lead performance, according to your own standard procedures (see further advice below). Undertake this: at three-month intervals (in clinic or via remote monitoring) to - monitor for HV lead noise using an unused EGM channel turn on RV AutoCapture™ (or equivalent) pacing to monitor pacing thresholds  and at six-month intervals (in clinic) to - ensure high voltage lead integrity (HVLI)  testing is performed. At box change, if a decision is made to continue to use the lead, ensure that the replacement device has remote/advanced monitoring capabilities. Consider the need for further examination e.g. by ECG or fluoroscopy*, if a lead failure is suspected. If a lead failure is confirmed, the risks and benefits of lead replacement options should be evaluated on a case-by-case basis in discussion with the patient. Note: Prophylactic lead explantation is not recommended, other than in exceptional clinical circumstances. * In all cases, the benefit of fluoroscopic screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000. Further advice Where appropriate for patients, follow-up should continue to include: > provocative testing (e.g. shoulder/arm movements and deep respiration), which may help reveal an   intermittent problem > increasing the detection time of the VT zone to reduce the risk of oversensing and inappropriate shocks > ensuring the SVT discriminators are on, where applicable > ensuring that the lead impedance alarms are programmed on. Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any patient alert. Report all lead adverse incidents to the MHRA and to St Jude Medical.