Model Number SC-1110 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 05/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model #: sc-2218-70, serial #: (b)(4).Description: linear st lead, 70 cm.
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Event Description
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A report was received that the patient was experiencing dizziness and the scs was not working properly.The patient will undergo an explant procedure.
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Manufacturer Narrative
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Additional information was received that no further course of action will be taken at this time.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices 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 was experiencing dizziness and the scs was not working properly.The patient will undergo an explant procedure.
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Search Alerts/Recalls
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