Model Number 2090 |
Device Problems
Device Difficult to Program or Calibrate (1496); Failure to Calibrate (2440); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 reported that the programmer stylus unable to be calibrated.It was further reported that the programmer was exposed to bed bugs infestation.The programmer is expected to be returned for service.There was no patient involvement.
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Manufacturer Narrative
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Further review prompted a change in the device analysis results.The change is reflected in this report under conclusion code(s).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 reported that the programmer stylus was unable to be calibrated.It was further reported that the programmer was exposed to a bed bugs infestation.The programmer remains in use.There was no patient involvement.
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Search Alerts/Recalls
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