Model Number SC-1110-02 |
Device Problems
Device Inoperable (1663); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/10/2018 |
Event Type
malfunction
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Event Description
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A report was received that the patients ipg was non functional.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Additional information was received that no device malfunction was suspected.
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Event Description
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A report was received that the patients ipg was non functional.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Additional information was received that the patients ipg would not kept charged.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted device was not returned to bsn as it was kept by the medical facility.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 patients ipg was non functional.The patient will undergo an ipg replacement procedure.
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Search Alerts/Recalls
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