Model Number SC-1110 |
Device Problems
Device Stops Intermittently (1599); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/25/2017 |
Event Type
malfunction
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Event Description
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A report was received that the patients ipg was not holding a full charge and was shutting off periodically.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Additional information was received that there will be no further course of action at this time.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 not holding a full charge and was shutting off periodically.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Additional information was received that the physician did not suspect device malfunction except for normal wear and tear.No further course of action needed at this time.
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Event Description
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A report was received that the patients ipg was not holding a full charge and was shutting off periodically.The patient will undergo an ipg replacement procedure.
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Search Alerts/Recalls
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