Model Number G247 |
Device Problems
Inaccurate Synchronization (1609); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ventricular Fibrillation (2130); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) induced a ventricular fibrillation episode.A shock was delivered in order to end the episode.It was suspected that the algorithm of the device was the root cause of the induced arrhythmia.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.
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Manufacturer Narrative
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This correction report is being submitted to inform this event is no longer considered reportable as the information received details concerns regarding device performance.Technical services clarified that the device was performing accordingly and that the rhythm of the patient was due to pre-ventricular contractions.Optimization options for the device were provided.There is no indication of product malfunction.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) delivered successfully appropriate shock therapy to convert the patient's self-conducted ventricular rhythm.Upon review, it was noticed that the condition of this patient initiated the arrhythmia.Reprogramming efforts were discussed and recommended.At this time, this crt-d remains in service and no adverse patient effects were reported.
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Search Alerts/Recalls
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