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..
[184468686]
Product analysis : analysis confirmed error upon startup. Stylus tip position on touch screen needs calibration. Electrocardiogram (ecg) failed during the functional test. Replaced link electronic module (lem) board with a salvaged part. Micro processor unit (mpu) board replaced. Connector touch screen cleaned and re-seated. Touch screen re-calibrated. Handle was cracked. Handle replaced. Software re-installed and updated to current version. Device was cleaned. Passed electrical safety test. Passed all final functional and system tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184468687]
It was reported that the programmer displayed an error during boot. The user was advised to return the programmer for repair. There was no patient involvement. 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 | 2182208-2020-00558 |
| MDR Report Key | 9865136 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2010-02-25 |
| 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 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Device Availability | N |
| 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 | 2067 | 2020-03-23 |