MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[177131752]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177131753]
It was reported that during an implant procedure, the analyzing function of the programmer was set ready to conduct pacing as requested by the physician when after ten minutes a message was displayed stating loss of communication between the programmer and the hosting tablet. The event occurred prior to pacing and it was noted that the patient had a high likelihood of becoming pacing dependent. A different model programmer was in readiness and used in the event to complete the procedure. Whilst communication was re-established with the programmer, the user did not switch back to it. The programmer remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188583072]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586650]
Product analysis: analysis of the device logs was able to confirm the customer comment that there was a loss of communication between the programmer and the hosting tablet. It was noted that wireless fidelity (wifi) was on and the possibility of wifi and bluetooth interference, with possibility of other signal interferences was noted. Significant latency was also observed. The exact reason for the loss of connection was not determined in the event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004593495-2020-00081 |
| MDR Report Key | 9648112 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2020-01-30 |
| 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 SMARTSYNC BASE |
| Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION |
| Product Code | DTC |
| Date Received | 2020-01-30 |
| Model Number | 24970A |
| Catalog Number | 24970A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-30 |