MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for CARELINK ENCORE PROGRAMMER 29901A manufactured by Plexus Manufacturing Sdn. Bhd.
[184469665]
Product analysis: analysis was able to confirm the customer comment that the programmer would not boot up past the logo screen until the screen was touched and that the cursor does not move. It was noted that the programmer was able to interrogate but not able to select however it did work with a known good display. Replaced computer platform (cp), reloaded and updated software and the device then passed all final functional and systems tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184469666]
It was reported that the programmer required multiple reboots before it could be used. It booted up successfully after three reboots but would then only interrogate the device. The screen was unresponsive to the stylus so the user was unable to program the device. The user had to reboot the programmer again. The programmer was returned for service. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00304 |
| MDR Report Key | 9865522 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-12-20 |
| 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 | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Street | BAYAN LEPAS FREE INDUSTRIAL ZO |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARELINK ENCORE PROGRAMMER |
| Generic Name | PROGRAMMER, PACEMAKER |
| Product Code | KRG |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 29901A |
| Catalog Number | 29901A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Address | BAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |