PACEART OPTIMA SYSTEM SOFTWARE
Received Oct 21, 2021 · Event occurred Oct 12, 2021
Report 2182208-2021-04191 · MDR key 12675816
Device
Generic name
Analyzer, Pacemaker Generator Function, Indire
Manufacturer
Medtronic, Inc.Model number
POS12D18Catalog number
POS12D18
Product problems
- Data Problem
- Data Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THE PROGRAMMER REPORT HAD SHOWN AN ESTIMATED LONGEVITY REMAINING OF 7.5 YEARS BUT THE PATIENT MANAGEMENT DATABASE APPLICATION SHOWED REMAINING LONGEVITY AT ONE YEAR AND THREE MONTHS. ADVISED THE PATIENT MANAGEMENT DATABASE APPLICATION HAS CALCULATIONS FOR LONGEVITY BASED ON DEVICE DATA, BUT SHOULD BE LISTING AS PROVIDED BY THE PROGRAMMER DATA. CALLER DID NOT HAVE ACCESS TO THE CUSTOMER'S PATIENT MANAGEMENT DATABASE APPLICATION TO REVIEW. CALLER WILL FOLLOW-UP WITH CUSTOMER AND HAVE THEM REACH OUT WITH ACCESS TO LOOK INTO SOME EXAMPLES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.