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Health Sciences Authority
Dear Healthcare Professional Letters

Potential risk of electrode body fracture with EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

7 December 2020

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals of the potential risk of electrode body fracture with the EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501). During assembly of the EMBLEM™ S-ICD Subcutaneous Electrode, a small amount of adhesive is applied to a location just distal to the proximal sense ring. Over time, mechanical stresses on the electrode body at this location may create the potential for a fatigue crack to initiate from the outer lumen. This crack then propagates inward towards the center-oriented distal sense conductor, eventually resulting in a fracture of the two high voltage conductors. Manifestation of this fracture can be detected through non-physiologic mechanical artifacts and/or the presence of a high impedance alert condition. If both high voltage conductors fracture, shock therapy will be unavailable. To date, there have been 27 reported electrode body fractures; the earliest indication of fracture presented at a median age of 9 months (range 2 to 33 months). There was one reported death in a patient for whom electrode replacement was recommended but not performed following electrode fracture. Healthcare professionals are advised to conduct remote monitoring and follow-up with patients regularly to facilitate detection of this issue. Suspected conductor fractures should be confirmed through imaging and if required, replacement surgery is to be conducted. Routine prophylactic replacement of an electrode without evidence of fracture is not recommended. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.