Model Number SC-1200 |
Device Problems
Failure to Charge (1085); Overheating of Device (1437); Telemetry Discrepancy (1629); Battery Problem: Low Impedance (2973); Wireless Communication Problem (3283)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/05/2018 |
Event Type
malfunction
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Event Description
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A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.
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Manufacturer Narrative
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Sc-1200 (b)(4) device evaluation indicated that the complaint was confirmed.The u1 application ic was damaged.The device would not be charged nor linked to a test remote control even after two charging attempts.The device was cut open, and the battery measured 3.9 volts.The device exhibited excessive sleep current leakage.A hot spot was observed on the component (28.0°c).The impedance between vh and ground was low.The reported complaint states patient underwent to mri and the ipg would not communicate immediately after the mri.
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Event Description
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A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.
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Manufacturer Narrative
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Additional information was received that the patients rc would not communicate with ipg after a magnetic resonance imaging (mri).The patient underwent an ipg replacement procedure and was doing well postoperatively.
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Event Description
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A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.
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Search Alerts/Recalls
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