Model Number PARADYM RF SONR CRT-D 9770 |
Device Problem
Defibrillation/Stimulation Problem (1573)
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Patient Problem
Loss of consciousness (2418)
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Event Date 08/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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The physician reported that the patient, implanted with a paradym rf device, collapsed just before discharge from hospital.An external defibrillator must be used for therapy since the icd did not deliver therapy.
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Manufacturer Narrative
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Detailed analysis of episodes stored in device memories showed that device behaved as programmed and as specified.No therapy was delivered by the icd, because the programmed persistencies for vt and vf were not reached.
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Event Description
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The physician reported that the patient, implanted with a paradym rf device, collapsed just before discharge from hospital.An external defibrillator must be used for therapy since the icd did not deliver therapy.
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Event Description
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The physician reported that the patient, implanted with a paradym rf device, collapsed just before discharge from hospital.An external defibrillator must be used for therapy since the icd did not deliver therapy.
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Search Alerts/Recalls
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