Model Number SC-1110-02 |
Device Problems
Telemetry Discrepancy (1629); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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A report was received that the patient was having difficulty communicating her remote control to the ipg.The physician suspected malfunction with the ipg due to failure to consistently connect.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Additional information was received that the patient underwent an ipg replacement procedure.It was also reported that the ipg was replaced also due to battery needing recharging constantly.The patient was doing well post operatively.The explanted device was not returned to bsn.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 patient was having difficulty communicating her remote control to the ipg.The physician suspected malfunction with the ipg due to failure to consistently connect.The patient will undergo an ipg replacement procedure.
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Search Alerts/Recalls
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