MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-10 for PACEART OPTIMA POS12D14 manufactured by Medtronic, Inc..
[5131644]
It was reported that the battery cell impedance graphs have been showing incorrect values in the patient management database application (db). Technical support (ts) explained that db take the data that is given so the graph should be based on whatever the data the device was sending. The client said that the transmissions were coming in from session sync (ss) or retrieve from programmer (rfp) and no one in the clinic is manually changing or adding any of the values in db. Ts asked the client to get save to disk files of the encounters for at least one of the patients so replicate. 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
[12660535]
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 | 2182208-2014-03724 |
| MDR Report Key | 4314110 |
| Report Source | 06 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-10-14 |
| Date Mfgr Received | 2014-10-14 |
| Date Added to Maude | 2014-12-18 |
| 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 | 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 CARDIAC RHYTHM HEART FAILURE |
| 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 | 2014-12-10 |
| 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 | 2014-12-10 |