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Model Number 6172 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
Injury
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Event Description
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It was reported that the lead was misplaced during the implant procedure, being intraventricular and not posterior, confirmed by a ct scan.In turn, surgical intervention was undertaken the day after implant to remove the lead.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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