This product is registered as a combination product. 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
It was reported that the patient reported fatigue and left pectoral stimulation and presented remotely via merlin. Net. Upon investigation, the right ventricular lead was noted with increased thresholds. The patient presented in clinic for a device check. Upon investigation, the patient was in high output mode with intermittent loss of capture. The patient was admitted and taken to the cath lab for lead repositioning. During procedure, the lead was found a little losse but still connected. Microdislodgement was suspected. No other product malfunction was noted on the lead. The lead was repositioned. The patient stayed overnight and discharged the following day after normal device check.
Patient Sequence No: 1, Text Type: D, B5