Model Number SC-8216-70 |
Device Problems
Kinked (1339); Material Separation (1562)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/01/2018 |
Event Type
malfunction
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Event Description
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A report was received that the patient was experiencing lack of coverage.It was noted that x-ray shows a paddle migration to c5 and 2 kinked contacts which are dislodged.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.
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Manufacturer Narrative
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A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
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Event Description
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A report was received that the patient was experiencing lack of coverage.It was noted that x-ray shows a paddle migration to c5 and 2 kinked contacts which are dislodged.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.
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Search Alerts/Recalls
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