MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-27 for PACEART OPTIMA SYSTEM SOFTWARE POS12D18 manufactured by Medtronic, Inc..
[186829572]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186829573]
It was reported that the patient management database application was filling in measurements that were misleading and could effect patient care. These measurements were not listed on the remote monitoring report. If the patient is in atrial fibrillation (af), it will fill in areas that may not appear to be correct. The issue was escalated for further investigation and resolution. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00396 |
| MDR Report Key | 9763918 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACEART OPTIMA SYSTEM SOFTWARE |
| Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT |
| Product Code | KRE |
| Date Received | 2020-02-27 |
| Model Number | POS12D18 |
| Catalog Number | POS12D18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |