Model Number SC-1132 |
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 09/06/2016 |
Event Type
malfunction
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Event Description
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A report was received that the patient was having difficulty charging the ipg.It was also noted that the remote control (rc) would not communicate to the ipg.The patient will undergo a revision procedure.
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Event Description
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A report was received that the patient was having difficulty charging the ipg.It was also noted that the remote control (rc) would not communicate to the ipg.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.The physician suspected device malfunction.The patient was doing well postoperatively.
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Event Description
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A report was received that the patient was having difficulty charging the ipg.It was also noted that the remote control (rc) would not communicate to the ipg.The patient will undergo an ipg replacement procedure.
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Manufacturer Narrative
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Sc-1132 sn (b)(4) device evaluation indicated that the complaint was confirmed.Upon receiving, the device measured 3.338 volts, and it was charged to 3.960 volts in one charging cycle.However, the charge and system data logs were corrupted, and the measurement of the battery internal resistance supported the battery tab anomaly.It was due to the intermittent battery tabs, and was the source of the charging and communication anomalies.
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Event Description
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A report was received that the patient was having difficulty charging the ipg.It was also noted that the remote control (rc) would not communicate to the ipg.The patient will undergo an ipg replacement procedure.
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Search Alerts/Recalls
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