Model Number 1192 |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 11/08/2021 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2021-06566.Related manufacturer reference number:3006705815-2021-06567.Related manufacturer reference number: 1627487-2022-00576.It was reported that the patient¿s therapy strength was decreasing on its own.Diagnostics revealed high impedance on both leads.X-ray showed that one of the leads was fractured and both anchors were broken.As such, surgical intervention may take place at a later date to address the issue.
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Manufacturer Narrative
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Date of event is estimated.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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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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Event Description
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Additional information revealed that the patient underwent surgical intervention on (b)(6) 2022 wherein the leads and anchors were explanted and replaced.Postoperatively, the patient has effective therapy.
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Search Alerts/Recalls
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