MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for PACEART SYSTEM GCIII manufactured by Medtronic, Inc..
[125772633]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[125772634]
It was reported that the caller stated that when the device was interrogated the device was elective replacement indicator (eri) with settings of vvi 65. After uploading the programmer data to the patient management database application, the atrial ohms were displayed as 67 ohms. The atrial lead was off due to the device being at eri and possibly due to an erroneous number during the data transfer. The caller was advised to test the lead during a generator change to ensure the atrial lead was functioning normally. The application remains in use. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2018-01986 |
| MDR Report Key | 8026346 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-10-31 |
| 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 | 0 |
| Brand Name | PACEART SYSTEM |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-10-31 |
| Model Number | GCIII |
| Catalog Number | GCIII |
| 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 | 2018-10-31 |