MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-06 for PACEART OPTIMA POS12D15 manufactured by Medtronic, Inc..
[72127255]
Patient Sequence No: 1, Text Type: N, H10
[72127256]
It was reported that the patient management database application displayed that the device had a battery life of 1 year 5 months remaining which was incorrect. The battery was at end of life. The customer corrected the information in the patient management database application, but requested that the issue be investigated. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[96236849]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[96236850]
It was further reported that the health professional discovered that the information wasn't system generated, but was hand entered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2017-00485 |
| MDR Report Key | 6467921 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-06 |
| Date of Report | 2017-01-24 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-04-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-04-06 |
| 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 | 2017-04-06 |