Model Number 00884450320563 |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that the hero device disconnected from the titanium connection and migrated to the right ventricle.Component was partially removed on (b)(6) 2020.No patient injury to report.
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Manufacturer Narrative
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A crucial components of the suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Search Alerts/Recalls
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