Model Number 53401 |
Device Problems
Intermittent Capture (1080); Device Sensing Problem (2917); Output Problem (3005)
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Patient Problem
No Code Available (3191)
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Event Date 10/30/2019 |
Event Type
Injury
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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 the external pulse generator (epg) was not pacing and sensing consistently.After placement of the pacing wire and prepping to set the pacer, there was very little sensing or capture getting up to about 15a and then after manipulating the connections the capture happened and the patient¿s chest jumped.Occasionally, the capture held and other times it did not and had to be adjusted again.Multiple cables and pacing wires were used for troubleshooting and the issues persisted.The epg was returned for service.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: analysis was unable to confirm the customer comment that the epg was not pacing and sensing consistently.Analysis did reveal that one chassis boss was damaged (stripped).All found defective parts were replaced and all other identified issues were resolved.The device then passed all functional tests.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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