MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-22 for CARELINK ENCORE PROGRAMMER 29901A manufactured by Plexus Manufacturing Sdn. Bhd.
[184417833]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184417834]
It was reported that the touch screen on the programmer suddenly stopped working. The programmer was restarted and the battery was removed but the issue remained. It was advised to returned the programmer for service. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00298 |
| MDR Report Key | 9863836 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-22 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-22 |
| Model Number | 29901A |
| Catalog Number | 29901A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-22 |