Model Number 103 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2016 |
Event Type
malfunction
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Event Description
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Around a month after a repositioning due to migration of the patient's generator, captured in mfr.Report # 1644487-2016-02776, a company representative interrogated the patient's device and noted it was pulse-disabled even though the battery icon showed full charge.System diagnostics confirmed device function.The device was able to be programmed back on.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
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Manufacturer Narrative
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Evaluation codes (refer to coding manual), corrected data: results code was inadvertently reported in the initial mdr.Results code was inadvertently excluded from the initial mdr.
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Event Description
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It was reported by the surgeon's office that electrocautery was not used during the repositioning surgery reported in mfr.Report # 1644487-2016-02776.They indicated that they were able to interrogate the generator after the surgery.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
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Event Description
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Additional programming history was reviewed from the date of the repositioning surgery.The internal data of the generator revealed that the patient's generator was pulse-disabled on the date of surgery.The information also revealed that the generator's voltage dropped sharply within two hours on the date of surgery.This drop in voltage into pulse-disabled status is consistent with the behavior of generators exposed to electrostatic discharge during the repositioning surgery reported in mfr.Report #1644487-2017-03249.Possible sources of electrostatic discharge during a repositioning surgery would be use of electrocautery around the generator or electrostatic discharge through the torque wrench.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
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Search Alerts/Recalls
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