Model Number SC-2408-56 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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Patient Problems
Scar Tissue (2060); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patient underwent a lead revision procedure, in which the existing lead was explanted and a new lead was implanted.It was indicated that the reason for the lead revision procedure was due to the original lead not being implanted correctly due to anatomical difficulties, and no device problems were noted.The explanted lead was discarded by the facility and will no be returned for analysis.The patient is doing well post operatively.
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Event Description
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It was reported that the patient underwent a lead revision procedure, in which the existing lead was explanted and a new lead was implanted.It was indicated that the reason for the lead revision procedure was due to the original lead not being implanted correctly due to anatomical difficulties, and no device problems were noted.The explanted lead was discarded by the facility and will no be returned for analysis.The patient is doing well post operatively.Additional information was received that the lead and contacts were found to be lying intradurally and that both the lead and the clik anchor were removed and replaced with a new device.
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Search Alerts/Recalls
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