Model Number 0672 |
Device Problems
Pocket Stimulation (1463); High Capture Threshold (3266)
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Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994)
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Event Date 03/06/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on the recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.Additional information received advised the device alerted for rv intrinsic amplitude out of range.The right ventricular automatic threshold (rvat) tests detected as suspended due to intrinsic beats and noise.The lv lead impedance noted to be increasing from 910 ohms to 1356 ohms.The last in-office threshold result was 2.8v (volts) @ 1.0ms (milliseconds).The programmed pacing output is fixed at 3v @ 1.0ms.Rapid atrial fibrillation (af) was noted, with ongoing heart logic elevation.Review of lead and programmed parameters was recommended.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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