Model Number 518-018 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Patient information unavailable.Relevant tests/ laboratory data unavailable.Other relevant history, pre-existing medical conditions unavailable.Device evaluation: the device was sent back in conjunction with other devices used and the lead.From the minimal information, a break in the braid and core mandrel was seen in the same location on the lld.It cannot be determined how the break occurred and more information has been requested from the physician.
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Event Description
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Lead extraction procedure commenced.During removal, the lead with the lld device inside got torn into two parts.Both parts successfully removed with intervention; patient was discharged in stable condition.
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Manufacturer Narrative
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Device re-evaluation: received additional info from physician/rep regarding the event.Re-evaluation performed by a cross functional engineering team on 12/14/2017.From this subsequent information obtained, the following conclusion was determined: the lead was compromised within the lld, which caused a high stress area on the lld leading to the lld breaking in the same location as the lead break.Results and conclusions codes added after device re-evaluation.
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Search Alerts/Recalls
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