Model Number RVDR01 |
Device Problems
Loss of Data (2903); Reset Problem (3019)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 09/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a power on reset occurred.Critical ram parity error occurred in (b)(6) on (b)(6) 2016.Por severity is low so the device should be able to fully recover after reset.
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Event Description
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It was reported that the patient complained of "feeling weird" and having their heart rate stuck at sixty-five beats per minute.It was further noted that a full electrical reset occurred due to a critical ram parity error.Reprogramming was performed to restore the device's previous settings.The implantable pulse generator (ipg) remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a power on reset occurred.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the patient was not feeling well.It was noted that a bit flip and a second full electrical reset occurred.The implantable pulse generator (ipg) was reprogrammed and remains in use.
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Search Alerts/Recalls
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