MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for CARELINK PROGRAMMER 2090 manufactured by Medtronic, Inc..
[187206203]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187206204]
It was reported that the programmer had a problem with stylus calibration, being an inch off. It was recommended that the device be returned for service and to try a different stylus. The device is to be returned for service. There was no patient complications associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[188928067]
Analysis was able to confirm the customers reported stylus calibration issue. The "xy/overlay cable" was reseated and the stylus was calibrated. Broken tabs on the power cord bay door were noted. The power cord bay was replaced. The broken left keyboard hinge was found to be broken and was replaced. Hard drive was reconfigured, reloaded and updated with the appropriate software. The programmer passed all final function and system tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188928068]
It was further reported that the stylus did not work in the bottom right of the screen. The device was returned for service. It has been further reported that there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00638 |
| MDR Report Key | 9908801 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2011-09-30 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| 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 | 2020-03-31 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| 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 | 2020-03-31 |