Related manufacturer reference number: 2017865-2023-00600.It was reported the patient presented remotely via merlin.Net.Review of the transmission revealed the right ventricular lead exhibited high pacing impedance, high defibrillation impedance, low to no sensing of r-waves, and a change in capture threshold.During surgery, the physician found the terminal pen was loose and able to be moved.The right ventricular lead was explanted and replaced.Upon connection to the implantable cardioverter defibrillator (icd), the issues persisted.The icd was explanted and replaced.The patient was in stable condition.
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A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events of failure to capture, failure to sense, high pacing impedance and high defibrillation impedance were confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.The cause of the anomalies was determined to be due to an anomalous integrated circuit.
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