STOCKERT 70 RF GENERATOR PDF

This device is used in conjunction with specializedtherapeutic catheters and a dispersive pad indifferent electrode to create a closed electrical circuit capable of delivering specified doses of RF energy. The RF energy is delivered to cardiac tissue thatforms unwanted electrical pathways that either drive or maintain arrhythmias. The RF energy heats the tissue such that it becomes denatured and no longer functional. This item will be shipped UPS ground.

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There was also electrical noise on all systems around it, carto 3 system, ep recorder and the anesthesia equipment. When the ablation catheter was re-connected to the stockert, the noise stopped. Upon further follow-up, it was confirmed that the noise was on all the channels, including the 12 leads of body surface ecgs and all ic intracardial recordings on both carto 3 and ep recording systems simultaneously. The noise was present on the vitals system as well.

The case was completed. Once the catheters were plugged in, the large artifact that seemed to be coming from the stockert vanished. The artifact during ablation was only present at certain times. The customer was able to come off ablation and start again at some spots, while on others the customer just ablated through the artifact.

No patient consequences was reported. Manufacturer Narrative Investigation is still in progress. A supplemental report on device evaluation will be submitted once it is completed. It was reported that during a procedure when the ablation catheter was disconnected from the stockert generator an audible clicking sound was heard coming from the generator.

When the ablation catheter was re-connected to the stockert the noise stopped. Upon further follow-up it was confirmed that the noise was on all the channels, including the 12 leads of body surface ecgs and all ic intracardial recordings on both carto 3 and ep recording systems simultaneously. The customer was contacted by biosense webster field service engineer multiple times however, the hospital ep lab staff did not provide any response.

At this point it is indicating that the customer is declining system service. The device history record for stockert generator serial number b 4 showed that no manufacturing or test failure was noted during the manufacturing cycle related to functionality of the device.

The device met all requirements prior to distribution.

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Biosense Webster Stockert 70 RF Generator with Global Port

There was also electrical noise on all systems around it, carto 3 system, ep recorder and the anesthesia equipment. When the ablation catheter was re-connected to the stockert, the noise stopped. Upon further follow-up, it was confirmed that the noise was on all the channels, including the 12 leads of body surface ecgs and all ic intracardial recordings on both carto 3 and ep recording systems simultaneously. The noise was present on the vitals system as well. The case was completed.

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