MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-08 for PACEART OPTIMA PAOPT16SUP manufactured by Medtronic, Inc..
[99818661]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99818662]
It was reported that the electrophysiology (ep) catheter laboratory staff attempted to import from an implantable device save-to-usb file into the patient management database application; however, there were some parameters that were incorrectly uploaded. The issue has been corrected in a newer version of the patient management database application. The application remains in use. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2018-00056 |
| MDR Report Key | 7253804 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2017-12-13 |
| Date Added to Maude | 2018-02-08 |
| 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 | 2018-02-08 |
| Model Number | PAOPT16SUP |
| Catalog Number | PAOPT16SUP |
| 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 | 2018-02-08 |