MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-09 for PACEART OPTIMA POS12D15 manufactured by Medtronic, Inc..
[47153649]
Patient Sequence No: 1, Text Type: N, H10
[47153650]
It was reported that the patient management database application displayed different left ventricular (lv) pacing values than a programmer or the remote monitoring network. The issue was escalated for investigation and it was determined that the lv pacing value in the application is different from the programmer and remote monitoring network because it shows the total time the left ventricle was paced in relation to the total event time and not just the pacing event time. The other two values show the amount of time the lv is pacing, with no right ventricular (rv) pacing, relative to total time of either ventricle pacing. It was noted that the application is operating as designed and the explanation was provided to the customer. The application remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[99025812]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2016-01656 |
| MDR Report Key | 5714608 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-09 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-06-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| 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 |
| Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT |
| Product Code | KRE |
| Date Received | 2016-06-09 |
| Model Number | POS12D15 |
| Catalog Number | POS12D15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-06-09 |