Model Number 5392 |
Device Problems
Connection Problem (2900); Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that one of the external pulse generator's cable connectors was broken.The generator has not been received into service.There was no patient involvement.
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Manufacturer Narrative
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Product analysis: analysis confirmed the stated reason for return of "one of the connectors of the cable is broken", the ventricular connector was broken.It was additionally noted that the hook assembly was broken.The patient connectors and the hook assembly were replaced.The device passed all tests with no visual or electrical anomalies.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the product was returned for service.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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