Model Number 1192 |
Device Problem
Fracture (1260)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Event date is estimated.
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Event Description
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Related manufacturer report number: 3006705815-2022-00686, 3006705815-2022-00687, 1627487-2022-00793.It was reported that the patient's lead migrated, and patient's anchor was fractured.Patient's lead migration was confirmed via x-rays.Surgical intervention was undertaken on (b)(6) 2022 in which the leads and anchors were explanted.Note: it is not known which lead migrated or which anchor fractured so both are being reported.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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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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