MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for PACEART OPTIMA POS12D15 manufactured by Medtronic, Inc..
[42790812]
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
[42790813]
It was reported that the patient management database application was showing right ventricular (rv) lead values on a single chamber device with a single lead implanted in the atrium. The caller was advised this may be a data mapping issue and has been escalated to the development team. No patient complications have been reported as a result of this event. On (b)(6) 2016, 07:03:01: it was later reported that the device manufacturer was contacted to fix how they are creating the file. Until the issue is resolved the data in the patient management database application will need to be manually fixed.
Patient Sequence No: 1, Text Type: D, B5
[62588887]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2016-01000 |
| MDR Report Key | 5559417 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-04-07 |
| 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 | 2016-04-07 |
| 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 | 2016-04-07 |