The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
Related manufacturer reference number- 2017865-2020-03573. Related manufacturer reference number- 2017865-2020-03574. It was reported that the pacer dependent patient presented in clinic for follow-up. Upon interrogation, the right atrial lead exhibited noise. It was also noted that the right ventricular lead exhibited low sensing and oversensing resulting in inhibition. The leads were noted to be fractured. The patient was in stable condition. On (b)(6) 2020, the leads were capped and replaced. During the procedure, the implantable cardioverter defibrillator was also explanted and replaced due to an unspecified reason.
Patient Sequence No: 1, Text Type: D, B5