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 2020-03-26 for CARELINK PROGRAMMER 2090 manufactured by Medtronic, Inc..
[187232571]
Event summary: analysis determined that the stylus pen pointer was physically offset on the screen. Clicking/selecting icons was not working. The pen stylus was changed and there was no difference. The user still could not enter the stylus calibration screen. It was confirmed that there was a deviation between the stylus and the cursor on the screen (diagonal from the lower left to the upper right corner). The xy board (display/touch screen) was our of specification. There was no paper in the printer drawer. Both keyboard hinges were broken, there was a cut in the cable from the stylus and the overall shielding was visible but the stylus was working correctly. There was a cut in the cable of from the radiofrequency head and the overall shielding was visible, but the radiofrequency head was working correctly. The cooling fan was noisy. The xy board was replaced. The touch screen connector was cleaned and re-seated. Touch screen parameters were reset and the touch screen was calibrated according to procedure. Paper was added. Both keyboard hinges were replaced. The stylus was replaced. The cooling fan was replaced. Software was re-installed and updated to the newest version. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187232572]
It was reported that the programmer was returned for corrective maintenance/repair. It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00589 |
| MDR Report Key | 9883379 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2009-03-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Returned To Mfg | 2019-07-05 |
| 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 | 2020-03-26 |