MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-10 for PACEART OPTIMA POS12D14 manufactured by Medtronic, Inc..
[16782528]
It was reported that the client mentioned several times that the data issues had not been fixed in the new release of the patient management database (db). The client would like it be fixed in the next release. The client had given a list of data issues to someone at human resources. The client has to manually change or add the data because the data was not coming in correctly. The client noted that the percentage of pacing for a device in managed ventricular pacing (mvp) mode populate erroneously, the single chamber pacing modes populate the upper tracking rate which does not apply to single chamber pacing, and the atrial refractory does not populate. Db remains in use. No patient involvement or complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[17075568]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2014-02590 |
| MDR Report Key | 4159036 |
| Report Source | 05 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-07-31 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-07-31 |
| Date Added to Maude | 2014-10-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| Manufacturer Street | 8200 CORAL SEA ST 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 | 2014-10-10 |
| Model Number | POS12D14 |
| Catalog Number | POS12D14 |
| 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 | 2014-10-10 |