MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for CARELINK PROGRAMMER 2090 manufactured by Medtronic, Inc..
[187204275]
Product analysis:analysis confirmed the customer comment. The pacemaker model list was found empty. Software reconfiguration was performed to eliminate possible software issues. The cord bay latch was broken, the keyboard hinge left and right were broken, the paper tray was nearly empty, the stylus tip position on the touch screen needed calibration, errors were found in the software history. The programmer failed on hdd during software update. The hdd was replaced. The programmer failed on parameter 1018f analog input/output test (link electronic module (lem) board related). The lem board was replaced. Software was re-installed and updated to the newest version. The cord bay was replaced, the keyboard hinge left and right were replaced, paper was added, the connector touch screen was cleaned and re-seated, the touch screen was calibrated according to procedure. All found defective parts were replaced and all other identified issues were resolved. The device then passed all final functional tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187204276]
It was reported that the programmer "pacemaker model list" was found completely empty. The pacemaker was returned for service. No patient complications have been reported as a result of this event. It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00564 |
| MDR Report Key | 9866401 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2011-05-20 |
| Date Added to Maude | 2020-03-23 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| 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 | CARELINK PROGRAMMER |
| Generic Name | PROGRAMMER, PACEMAKER |
| Product Code | KRG |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2019-12-05 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-23 |