Model Number SC-8216-70 |
Device Problem
Material Separation (1562)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/04/2017 |
Event Type
Injury
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Event Description
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A report was received that the patient underwent an explant procedure due to ineffective therapy.During the procedure the physician was able to remove parts of the lead but the contacts remained inside the patient.The physician later performed a laminectomy to remove the contacts from the patient.
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Manufacturer Narrative
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The explanted lead was not returned to bsn.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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Event Description
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A report was received that the patient underwent an explant procedure due to ineffective therapy.During the procedure the physician was able to remove parts of the lead but the contacts remained inside the patient.The physician later performed a laminectomy to remove the contacts from the patient.
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Search Alerts/Recalls
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