Model Number 53401 |
Device Problems
Pacing Intermittently (1443); Device Sensing Problem (2917)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/30/2019 |
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 the external pulse generator (epg) was not pacing and sensing consistently.Multiple cables and pacing wires were used for troubleshooting and the issues persisted.The device is expected to be returned for service but the current status is unknown.There was no patient involvement.
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Manufacturer Narrative
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Product event summary: analysis was unable to confirm the customer comments that the external pulse generator (epg) was not pacing or sensing consistently.The device passed all automated, bench, and visual testing with no anomalies observed.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 epg was returned for service.
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Search Alerts/Recalls
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