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- Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation
Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation
- Date : 21/06/2016
- Objet : Point d'information autorité compétente
- Dispositif : Sonde de resynchronisation cardiaque / modèles: 1056T, 1058T, 1156T, 1158T
- Cause(s) : Il existe des risques d'usure et/ou d'abrasion des fils électriques des sondes concernées.
- Risque(s) : Symptômes empirés d'insuffisance cardiaque
- Lien : https://www.gov.uk/drug-device-alerts/four-bipolar-quicksite-and-quickflex-lead-models-risk-of-worsening-heart-failure-symptoms-due-to-wear-and-or-abrasion-of-lead-insulation-after-implantation