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..
[47149149]
Patient Sequence No: 1, Text Type: N, H10
[47149150]
It was reported that data imported into the patient management database application from a competitor monitor was not correct. The customer observations were reported to development for escalation. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[51947028]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2016-01550 |
| MDR Report Key | 5712858 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-09 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| 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 |