Model Number PROGRAMMER |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Further information was requested but not received.This report is being submitted for the programmer as a part of the programmer longevity estimator software error field action (fda recall number: fa-q222-crm1) set of complaints.Should any additional information be obtained, a supplemental report will be issued.
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Event Description
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Related manufacturer report number 2017865-2023-20899.It was reported that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.It is unknown if the programmer was running the updated software version at the time the longevity discrepancy was discovered.The patient¿s pulse generator was explanted, however, it is unknown if the device had reached elective replacement indicator (eri) level.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This report is being submitted for the programmer as a part of the programmer longevity estimator software error field action (fda recall number: fa-q222-crm1) set of complaints.Should any additional information be obtained, a supplemental report will be issued.
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Event Description
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Additional information was received indicating that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.The patient¿s pulse generator was explanted prior to reaching its elective replacement indicator (eri).No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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