Model Number M1663A |
Device Problem
Device Operates Differently Than Expected (2913)
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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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An ecg leads related issue could prevent demand mode pacing or delay therapy/treatment.We are still in the process of assessing if there's a risk to health.This complaint is being reported in order to meet the reporting deadlines.A follow up report will be submitted once the investigation is complete.
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Event Description
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The customer reported failure of the m1663a, ecg trunk cable.The customer did not report any patient/user involvement.There was no reported patient incident/injury.
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Event Description
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The customer reported failure of the m1663a, ecg trunk cable.The device was in clinical use at the time the issue was discovered.The customer did not report any patient/user involvement.There was no reported patient incident/injury.
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Search Alerts/Recalls
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