Model Number SC-1132 |
Device Problem
Device Inoperable (1663)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model #: sc-8336-70, serial #: (b)(4), description: coveredge 32, 70 cm 4x8 surgical lead.
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Event Description
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A report was received that the patients device was non-functional.The patient will undergo an explant procedure.
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Manufacturer Narrative
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Additional information was received that the patient underwent an explant procedure due to device was not giving pain relief.No device malfunction was suspected.
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Event Description
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A report was received that the patients device was non-functional.The patient will undergo an explant procedure.
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Search Alerts/Recalls
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