PACEART OPTIMA SYSTEM SOFTWARE
Received Dec 3, 2021 · Event occurred Nov 22, 2021
Report 2182208-2021-04736 · MDR key 12923872
Device
Generic name
Analyzer, Pacemaker Generator Function, Indire
Manufacturer
Medtronic, Inc.Model number
POS12D18Catalog number
POS12D18
Product problems
- Data Problem
- Data Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED ISSUE IS ASSOCIATED WITH A KNOWN ADVISORY RELATED TO THE POTENTIAL FOR MEDTRONIC PROGRAMMER AND REMOTE MONITORING SOFTWARE APPLICATIONS TO DISPLAY AN INACCURATE REMAINING LONGEVITY ESTIMATE. A RECALL NUMBER IS NOT AVAILABLE IN THIS INSTANCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE REPORT EXHIBITED A SHORTER THAN EXPECTED LONGEVITY ESTIMATE DUE TO A PATIENT MANAGEMENT DATABASE APPLICATION SOFTWARE ESTIMATOR ERROR. THE CORRECT CALCULATION WAS PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.