Corner fracture: an unexpected lead complication in subcutaneous implantable cardioverter-defibrillator

Subcutaneous implantable cardioverter‐defibrillator electrode fracture: Follow‐up, troubleshooting, and evaluation

“…important failures. [6][7][8][9] Interestingly, fractures in several cases were severe enough to cause complete or near-complete physical separation of the electrode into two pieces. One fracture was similar to ours occurring near the electrode-header interface in the pocket.…”

“…7 In the other cases, the fracture was just distal to the proximal sense ring, which is a specific site recently identified in a safety advisory by the manufacturer, as prone to S-ICD electrode (Emblem model 3501) body fracture. 5,8,9 Among published cases of S-ICD electrode failure, a common failure mode is a location at or near a fixation site (i.e., in the axilla near the electrode-header interface or in the xiphoid near the proximal ring suture position) that is facilitated by an electrode bend close to these fixed sites. [6][7][8][9] Repeated movements may lead to excessive electrode bending at these fixed sites that can result in cyclic, fatigue stress fractures of conductor cables and appear to be the root-cause failure mechanism.…”

“…5,8,9 Among published cases of S-ICD electrode failure, a common failure mode is a location at or near a fixation site (i.e., in the axilla near the electrode-header interface or in the xiphoid near the proximal ring suture position) that is facilitated by an electrode bend close to these fixed sites. [6][7][8][9] Repeated movements may lead to excessive electrode bending at these fixed sites that can result in cyclic, fatigue stress fractures of conductor cables and appear to be the root-cause failure mechanism. The microscopic conductor filar cracks seen in this case would be expected to grow as continued stress is applied repeatedly to the electrode with eventual physical disruption and potential for fatigue failure without warning before an inappropriate shock.…”