Model Number H403023 |
Device Problem
Pacing Problem (1439)
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Patient Problem
Ventricular Fibrillation (2130)
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Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
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Event Description
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During a ventricular tachycardia procedure, the patient went into ventricular fibrillation.The stimulator would not sense and pacing was applied on the r wave causing fibrillation.The patient was required to restore sinus rhythm.The procedure was completed successfully.
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Manufacturer Narrative
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One workmate¿ claris¿ ep-4¿ cardiac stimulator was returned for investigation.Ac power was applied to the ep-4 stimulator which successfully executed the power on self-test.Preliminary voltage measurements confirmed system voltages to be within the specified limits.Functional testing confirmed sensing features operate as per design and intent.Sense level testing was performed during the hardware evaluation and confirmed normal sense functionality.Based on the information provided to abbott and the investigation performed, the root cause of the induced arrhythmia could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.
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Search Alerts/Recalls
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