Model Number SONATA |
Device Problems
Device Operates Differently Than Expected (2913); Electrical Shorting (2926)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/11/2015 |
Event Type
Injury
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Event Description
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In situ measurements performed during the initial activation showed all the electrode channels either in status high or involved in short circuit.During intra op measurements all channels except one were ok.No trauma has been reported.
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Manufacturer Narrative
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(b)(6).The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Manufacturer Narrative
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Additional information: according to the currently available information, it appears there is a problem with the active electrode, most likely due to excessive mechanical stress to it.To determine an exact root cause a device investigation of the explanted device is necessary.If and when the patient is explanted, the complaint will be reopened.
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Event Description
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In-situ measurements performed during the initial activation showed all the electrode channels either in status high or involved in short circuit.During intra op measurements all channels except one were ok.No trauma has been reported.
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Manufacturer Narrative
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Additional information: according to the currently available information, it appears there is a problem with the active electrode, most likely due to excessive mechanical stress to it.To determine an exact root cause a device investigation of the explanted device is necessary.The patient has been explanted, but the device has not been received yet.
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Event Description
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In-situ measurements performed during the initial activation showed all the electrode channels either in status high or involved in short circuit.During intra op measurements all channels except one were ok.No trauma has been reported.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the patient report appear to match the damage found.This is a final report.
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Event Description
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In-situ measurements performed during the initial activation showed all the electrode channels either in status high or involved in short circuit.During intra op measurements all channels except one were ok.No trauma has been reported.
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Search Alerts/Recalls
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